Manufacturers’ alerts

The following is information SHPA has received from medicines manufacturers, such as alerts regarding supply problems, discontinued items etc, which may be useful to SHPA members.

Other resources:

  • TGA Medicine Shortages Information Initiative which provides up-to-date information about temporary or permanent disruption (discontinuation) to the supply of a medicine in Australia. You can also subscribe to updates so you will receive an email when there is a new or updated medicine shortage reported by sponsors to the TGA and published on the Medicine Shortages Information website. 
  • TGA Australian Recall Actions for recalls of medicines, medical devices and biologicals.
  • TGA Alerts which advises consumers, health professionals and industry about new safety information regarding therapeutic product.

Shortage of APO-AMOXYCILLIN amoxicillin (as trihydrate) 125mg/5mL and 250mg/5mL powder for suspension bottle
28 November

Due to the shortage of Australian registered APO-AMOXYCILLIN amoxicillin (as trihydrate) 125mg/5mL and 250mg/5mL powder for suspension bottle (AUST R 137882 & 137883), LINK has arranged the supply of an alternative product, Amoxicillin 125mg/5mL and 250mg/5ml Powder for Oral Suspension Sugar Free (Flamingo Pharma) registered and marketed in the United Kingdom.

Medicine Shortage Update: Ozempic (semaglutide) and Trulicity (dulaglutide)
24 November

Until the end of March 2023, there will be no further supplies of Ozempic available in Australia and access to Trulicity is expected to be very limited. To assist consumers and health professionals, the Therapeutic Goods Administration (TGA) has published two web pages, providing practical information and advice about these shortages including a link to new clinical guidelines from the Royal Australian College of General Practitioners (RACGP), answers to questions we have received about Ozempic and Trulicity availability and alternative treatments.

Shortage of Actilyse alteplase (rch) 50mg powder for injection vial with diluent vial (ARTG 17905)
23 November

The Australian registered medicine Actilyse alteplase (rch) 50mg powder for injection vial with diluent vial (ARTG 17905) sponsored by Boehringer Ingelheim Pty Ltd is currently in shortage due to unexpected increase in demand due to the shortage of Metalyse (tenecteplase). Pro Pharmaceuticals Group has arranged for the supply of an alternative product, ACTIVASE® rt-PA alteplase for injection, Lyophilized powder for injection - 100 mg (Canada).

Shortage of DANTRIUM dantrolene sodium hemiheptahydrate 20mg powder for injection vial and alternative supply arrangement
22 November

Due to the shortage of Australian registered DANTRIUM dantrolene sodium hemiheptahydrate 20mg powder for injection vial (AUST R 14435), LINK has arranged the supply of an alternative product, REVONTO dantrolene sodium for injection 20mg/vial registered and marketed in the United States of America.

Shortage of DITROPAN oxybutynin hydrochloride 5mg tablets
18 November

Due to the shortage of DITROPAN oxybutynin hydrochloride 5mg tablets (AUST R 48965) ORSPEC Pharma has arranged the supply of an alternative product on a temporary basis.

Availability of METRONIDAZOLE 200MG/5ML ORAL SUSPENSION (ROSEMONT) alternative supply arrangement
17 November

Due to the shortage of the Australian registered FLAGYL S (metronidazole benzoate) ORAL SUSPENSION ARTG: 27501, Reach Pharmaceuticals has arranged the supply of an alternative product called METRONIDAZOLE 200MG/5ML ORAL SUSPENSION (ROSEMONT), registered and marketed in the United Kingdom.

Shortage of ALPHAMOX 250mg and 500mg amoxicillin (as trihydrate) capsule blister pack
8 November

Due to the shortage of Australian registered ALPHAMOX 250mg and 500mg amoxicillin (as trihydrate) capsule blister pack, LINK has arranged the supply of an alternative product, AMOXICILLIN 250mg and 500mg CAPSULES BP (Athlone) registered and marketed in the United Kingdom.

Shortage of OZEMPIC 1 mg semaglutide (rys) 1.34 mg/mL solution for injection pre-filled pen
21 October

The Australian registered medicine, OZEMPIC 1 mg semaglutide (rys) 1.34 mg/mL solution for injection pre-filled pen AUST R: 315107 Active ingredients: Semaglutide Sponsor: Novo Nordisk Pharmaceuticals Pty Ltd is currently in shortage. Pro Pharmaceuticals Group has arranged for the supply of an alternative product, Ozempic 1 mg solution for injection pre-filled pen (Croatia).

Shortage of AMOXYCILLIN SANDOZ amoxicillin trihydrate 250mg/5mL powder for oral suspension bottle ARTG: 93720
21 October

The Australian registered medicine, AMOXYCILLIN SANDOZ amoxicillin trihydrate 250mg/5mL powder for oral suspension bottle ARTG: 93720 is currently in shortage due to manufacturing issues. Pro Pharmaceuticals Group has arranged for the supply of an alternative product, AMOXICILLIN 250MG/5ML ORAL SUSPENSION SUGAR FREE BP (ATHLONE).

Shortage of OZEMPIC 1 mg semaglutide (rys) 1.34 mg/mL solution for injection pre-filled pen
5 October

The Australian registered medicine, OZEMPIC 1 mg semaglutide (rys) 1.34 mg/mL solution for injection pre-filled pen AUST R: 315107 (Sponsor: Novo Nordisk Pharmaceuticals Pty Ltd) is currently in shortage. Pro Pharmaceuticals Group has arranged for the supply of an alternative product, OZEMPIC semaglutide 1mg solution for injection pre-filled pen (UK)..

Shortage of OZEMPIC 0.25/0.5 mg semaglutide (rys) 1.34 mg/mL solution for injection pre-filled pen
5 October

The Australian registered medicine, OZEMPIC 0.25/0.5 mg semaglutide (rys) 1.34 mg/mL solution for injection pre-filled pen AUST R: 308324 (Sponsor: Novo Nordisk Pharmaceuticals Pty Ltd) is currently in shortage. Pro Pharmaceuticals Group has arranged for the supply of an alternative product, OZEMPIC semaglutide 0.25mg solution for injection pre-filled pen (UK).

Update on Availability of Trulicity® (dulaglutide) 1.5mg
23 September

Further to their update on 2 September 2022, Eli Lilly Australia (Lilly) anticipates the global supply pressures resulting from increased demand for their Type 2 Diabetes (T2D) medication, Trulicity (dulaglutide), will extend beyond 31 December 2022 and into the foreseeable future.

Shortage of ZYPREXA IM olanzapine 10mg powder for injection vial and alternative supply arrangement
21 September

Due to the shortage of Australian registered ZYPREXA IM olanzapine 10mg powder for injection vial (AUST R 76867), LINK has arranged the supply of an alternative product, Olanzapine for intramuscular injection 10mg single dose vial (AuroMedics)) registered and marketed in the United States of America.

Shortage of AMOXYCILLIN SANDOZ amoxicillin trihydrate 250mg/5mL powder for oral suspension bottle ARTG: 93720
19 September

The Australian registered medicine, AMOXYCILLIN SANDOZ amoxicillin trihydrate 250mg/5mL powder for oral suspension bottle ARTG: 93720 sponsored by Sandoz Pty Ltd is currently in shortage due to manufacturing issues. Pro Pharmaceuticals Group has arranged for the supply of an alternative product, Amoxicillin Powder for Oral Suspension 250mg/5ml (West-Ward).

Shortage of AMCLAVOX DUO FORTE 875/125, amoxicillin (as trihydrate) 875 mg and clavulanic acid (as potassium) 125 mg tablets blister pack
15 September

Due to the shortage of Australian registered AMCLAVOX DUO FORTE 875/125, amoxicillin (as trihydrate) 875 mg and clavulanic acid (as potassium) 125 mg tablets blister pack AUST R: 288119, LINK has arranged the supply of an alternative product, Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Aurobindo) registered and marketed in the United States of America.

Pro Pharma Amoxicillin Powder for Oral Suspension 250mg5ml
13 September

Eli Lilly Australia (Lilly) has been and is continuing to experience an unanticipated increase in demand of our Type 2 Diabetes (T2D) medication, Trulicity (dulaglutide). This increase is driven by the supply issues of Ozempic® (semaglutide), another pharmaceutical company’s T2D medication.  On 4 August 2022, the expected period of semaglutide shortage in Australia was updated on the TGA medicine shortage database to 31 December 2022. As a result, Lilly has extended the Limited Availability status for Trulicity on the TGA medicine shortage database to 31 December 2022.

DHCPL Amoxicillin powder for oral suspension
12 September

Due to the shortage of Australian registered AMOXYCILLIN SANDOZ amoxicillin trihydrate 250mg/5mL powder for oral suspension bottle ARTG: 93720, LINK has arranged the supply of an alternative product, Amoxicillin powder for oral suspension 250mg/5mL (West-Ward) registered and marketed in the United States of America.

Update on Availability of Trulicity® (dulaglutide) 1.5mg
2 September

Eli Lilly Australia (Lilly) has been and is continuing to experience an unanticipated increase in demand of our Type 2 Diabetes (T2D) medication, Trulicity (dulaglutide). This increase is driven by the supply issues of Ozempic® (semaglutide), another pharmaceutical company’s T2D medication.  On 4 August 2022, the expected period of semaglutide shortage in Australia was updated on the TGA medicine shortage database to 31 December 2022. As a result, Lilly has extended the Limited Availability status for Trulicity on the TGA medicine shortage database to 31 December 2022.

Shortage of DITROPAN oxybutynin hydrochloride 5mg tablets
1 September

Due to the shortage of DITROPAN oxybutynin hydrochloride 5mg tablets (AUST R 48965). ORSPEC Pharma has arranged the supply of an alternative product on a temporary basis.

Shortage of AUGMENTIN DUO FORTE tablet blister pack 875mg/125mg (Amoxicillin Trihydrate and Potassium Clavulanate)
31 August

The Australian registered medicine, AUGMENTIN DUO FORTE tablet blister pack 875mg/125mg (Amoxicillin Trihydrate and Potassium Clavulanate) AUST R: 54900 sponsored by Aspen Pharmacare Australia is currently in shortage due to an unexpected increase in consumer demand. Pro Pharmaceuticals Group has arranged for the supply of an alternative product, AMOXICILLIN AND CLAVULANATE POTASSIUM tablets 875mg/125mg (Micro Labs).

Availability of OLENA fluoxetine hydrochloride 20 mg dispersible tablet
25 August

Due to the shortage of the Australian registered ZACTIN fluoxetine hydrochloride 20 mg dispersible tablet (ARTG 90913), Reach Pharmaceuticals has arranged the supply of an alternative product called OLENA fluoxetine hydrochloride 20 mg dispersible tablet, registered and marketed in the United Kingdom.

AMOXICILLIN 250MG/5ML ORAL SUSPENSION SUGAR FREE BP (KENT) - alternative supply arrangement
24 August

Due to the shortage of the Australian registered AMOXYCILLIN SANDOZ amoxicillin trihydrate 250mg/5mL powder for oral suspension bottle ARTG: 93720, Reach Pharmaceuticals has arranged the supply of an alternative product called AMOXICILLIN 250MG/5ML ORAL SUSPENSION SUGAR FREE BP (KENT), registered and marketed in the United Kingdom.

Shortage of FLAGYL metronidazole 400 mg tablet blister pack and alternative supply arrangement
23 August

Due to the shortage of Australian registered FLAGYL metronidazole 400 mg tablet blister pack (AUST R 160174), LINK has arranged the supply of an alternative product, Metronidazole 400mg tablets (Crescent Pharma) registered and marketed in the United Kingdom.

Availability of DUKAL Povidone-Iodine USP 10% sterile solution pouch - under alternative supply arrangement
16 August

Due to the discontinuation of the Australian registered POVIDONE-IODINE SOLUTION 10%w/v cutaneous solution ampoule, 30mL ARTG 12643, Reach Pharmaceuticals has arranged the supply of the alternative product called DUKAL Povidone-Iodine USP 10% sterile solution pouch registered and marketed in the United States.

Supply of BENPEN® (benzylpenicillin [as benzylpenicillin sodium]) 1.2g and 3g resumes
16 August

CSL Seqirus has received initial supplies of BENPEN 1.2g Powder for Injection and expect stock to be available in all states this week (mid-August). BENPEN 3g Powder for Injection was back in stock from late July. BENPEN (benzylpenicillin [as benzylpenicillin sodium]) is a narrow spectrum intravenous penicillin used in the treatment of serious infections such as moderate to severe pneumonia, wound infections, sepsis and meningitis.  

Shortage of DITROPAN oxybutynin hydrochloride 5mg tablets
4 August

Due to the shortage of DITROPAN oxybutynin hydrochloride 5mg tablets (AUST R 48965) ORSEPC Pharma has arranged the supply of an alternative product on a temporary basis.

Shortage of DBL ACETYLCYSTEINE, injection concentrate acetylcysteine 2 g/ 10 mL ampoule product and alternative supply arrangement
4 August

Due to the shortage of DBL ACETYLCYSTEINE injection concentrate acetylcysteine 2 g/ 10 mL injection ampoule (AUST R121503), ORSEPC Pharma has arranged the supply of an alternative product on a temporary basis.

Discontinuation of NARDIL phenelzine 15mg (as sulfate) tablet bottle and alternate supply arrangement
2 August

The Australian registered medicine, NARDIL phenelzine 15mg (as sulfate) tablet bottle (AUST R 93600), sponsored by Link Pharmaceuticals has been discontinued.
Medsurge has been able to arrange for the supply of NARDIL* Phenelzine Sulfate 15mg Tablets USP bottle (Canada) as an alternative product on a temporary basis.

Recall of Xylocaine 2%, with Epinephrine
29 July

The Canadian supplier of Xylocaine 2% has incorrectly shipped a product which contains preservative. There is a chance that the distributor of this product has supplied your pharmacy with Xylocaine 2%, containing preservative rather than Xylocaine 2%, without preservative. The administration of Xylocaine with preservative may cause patient harm particularly if administered via intrathecal or epidural routes.

As the packaging is similar (see images below), pharmacy departments are asked to be vigilant when receiving and dispensing Xylocaine 2%. If your pharmacy has received Xylocaine 2% containing preservative from batch #9949864 instead of Xylocaine 2% without preservative, you are asked to:

  • quarantine this stock until further notice,
  • notify your pharmaceutical distributor of the stock error.

Shortage of SULFAMETHOXAZOLE 400 MG AND TRIMETHOPRIM 80 MG CONCENTRATE INJECTION ampoule and alternative supply arrangement
27 July

Due to a shortage of the Australian registered DBL™ SULFAMETHOXAZOLE 400 MG AND TRIMETHOPRIM 80 MG CONCENTRATE INJECTION BP, 5mL ampoules (AUST R 16293), LINK has arranged the supply of an alternative product. LINK can supply Co-Trimoxazole 16 mg/80 mg per mL for Infusion (80 mg trimethoprim/400 mg sulfamethoxazole per 5 mL ampoules), registered and marketed in the United Kingdom.

Co-Trimoxazole 16 mg/80 mg per mL for Infusion are NOT registered in Australia and supply is granted under an exemption granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 31 March 2023.

Notification of out-of-stock period for Empliciti (elotuzumab) 300mg vial
27 July

The out-of-stock issue for Empliciti (Elotuzumab) 300mg Vial has been resolved at this time.

BENPEN benzylpenicillin (as sodium) 3 g and 1.2 g powder for injection vial – extension to 1st Sept 2022
18 July

Pro Pharmaceuticals Group (ProPG) advises that due to a shortage of Australian registered BENPEN benzylpenicillin (as sodium) 3g and 1.2g powder for injection vial, AUST R: 10326. ProPG has arranged for an alternative product Benzylpenicillin sodium 1200 mg powder for injection (Genus Pharmaceuticals). The S19A product is registered and marketed in the UK and the supply is authorized under an exemption granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 1st September 2022.

Empliciti (elotuzumab) 300mg lyophilized powder for inteavenous infusion vial - notification of out-of-stock period
15 July

Bristol Myers Squibb Australia Pty Ltd (BMS) advises of an out-of-stock period for Empliciti (elotuzumab) 300mg lyophilized powder for IV infusion vial. This out-of-stock period is anticipated to last approximately 2 weeks.

METALYSE tenecteplase (rch) 50mg powder for injection vial plus prefilled syringe AUST R: 75013 - shortage and alternative supply arrangement
12 July

Pro Pharmaceuticals Group (ProPG) advises that due to a shortage of Australian registered METALYSE tenecteplase (rch) 50mg powder for injection vial plus prefilled syringe AUST R: 75013. ProPG has arranged for an alternative product TNKASE tenecteplase 50mg powder for solution kit (Canada). The S19A product is registered and marketed in the USA and the supply is authorized under an exemption granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 31 January 2024.

METALYSE tenecteplase (rch) 50mg powder for injection vial plus prefilled syringe AUST R: 75013 - shortage and alternative supply arrangement
12 July

Pro Pharmaceuticals Group (ProPG) advises that due to a shortage of Australian registered METALYSE tenecteplase (rch) 50mg powder for injection vial plus prefilled syringe AUST R: 75013. ProPG has arranged for an alternative product TNKASE tenecteplase 50mg powder for solution kit (USA). The S19A product is registered and marketed in the USA and the supply is authorized under an exemption granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 31 January 2024.

OZEMPIC 0.25/0.5 mg semaglutide (rys) 1.34 mg/mL solution for injection pre-filled pen - shortage and alternative supply arrangement
1 July

Pro Pharmaceuticals Group advises OZEMPIC 0.25/0.5 mg semaglutide (rys) 1.34 mg/mL solution for injection pre-filled pen is currently in shortage due to an unexpected increase in consumer demand. Pro Pharmaceuticals Group has arranged for the supply of an alternative product, Ozempic 0.25mg & 0.5mg solution for injection in pre-filled pen (USA). This product is NOT registered in Australia and supply is authorised under an exemption granted by the Therapeutic Goods Administration (TGA) under section 19A of the Therapeutic Goods Act 1989 until 30th September 2022.

OZEMPIC 0.25/0.5 mg semaglutide (rys) 1.34 mg/mL solution for injection pre-filled pen - shortage and alternative supply arrangement
27 June

Pro Pharmaceuticals Group advises OZEMPIC 0.25/0.5 mg semaglutide (rys) 1.34 mg/mL solution for injection pre-filled pen is currently in shortage due to an unexpected increase in consumer demand. Pro Pharmaceuticals Group has arranged for the supply of an alternative product, Ozempic 0.25mg & 0.5mg solution for injection in pre-filled pen (USA). This product is NOT registered in Australia and supply is authorised under an exemption granted by the Therapeutic Goods Administration (TGA) under section 19A of the Therapeutic Goods Act 1989 until 30th September 2022.

DITROPAN oxybutynin hydrochloride 5mg tablet bottle AUST R: 48965 - shortage and alternative supply arrangement
24 June

Pro Pharmaceuticals Group (ProPG) advises that due to a shortage of Australian registered DITROPAN oxybutynin hydrochloride 5mg tablet bottle AUST R: 48965. ProPG has arranged for an alternative product Oxybutynin Chloride Tablets, USP 5mg (Novitium Pharma, USA) . The S19A product is registered and marketed in the USA and the supply is authorized under an exemption granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 31 January 2023.

Supply of TRULICITY® (DULAGLUTIDE) 1.5 MG in Australia - limited availability expected until 31 August 2022
21 June

Eli Lilly Australia (Lilly) has been and is continuing to experience an unanticipated increase in demand for TRULICITY® (dulaglutide) 1.5 mg, a once-weekly GLP-1 RA for adults with Type 2 diabetes (T2D). On 21 June 2022 Trulicity was listed on the TGA medicine shortage database with Limited Availability expected until 31 August 2022. While stock of Trulicity 1.5 mg is still available in Australia, increased demand may lead to temporary delays, interruptions and/or shortages in stock available through wholesalers and at pharmacies. To minimise interruptions or delays in treatment for patients, Lilly is working with our partners in endeavouring to distribute available stock across the supply chain as equitably as possible and with a focus on patients prescribed Trulicity for T2D. During this period, Lilly recommends that pharmacists consider the [linked] to help manage access to Trulicity for patients with T2D.

BCG VACCINE injection - discontinuation and alternative supply arrangement
21 June

Due to the discontinuation of the Australian registered BCG VACCINE Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain) – AUST R 53569, LINK has arranged the supply of an alternative product. LINK can supply BCG Vaccine AJV - Mycobacterium bovis BCG (Bacillus Calmette-Guerin), Danish strain 1331 (AJ Vaccines) with Diluted Sauton AJV, registered and marketed in New Zealand. BCG Vaccine AJV - Mycobacterium bovis BCG (Bacillus Calmette-Guerin), Danish strain 1331 (AJ Vaccines) with Diluted Sauton AJV is NOT registered in Australia and supply is authorised under an exemption granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 30 June 2024.

POVIDONE-IODINE SOLUTION 10%w/v cutaneous solution ampoule - discontinuation and and alternative supply arrangement
17 June

Due to the discontinuation of Australian registered POVIDONE-IODINE SOLUTION 10%w/v cutaneous solution ampoule (Aust R 12643), LINK has arranged the supply of an alternative product, Aplicare 10% Sterile Povidone-Iodine Liquid Pouch registered and marketed in the United States of America. Aplicare 10% Sterile Povidone-Iodine Liquid Pouch is NOT registered in Australia and supply is authorised under an approval granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 30 June 2023

DAUNORUBICIN (as hydrochloride) 20mg/10mL injection vial - shortage and alternative supply arrangement
7 June

Due to the shortage of Australian registered Pfizer (Australia) DAUNORUBICIN (as hydrochloride) 20mg/10mL injection vial (AUST R 12723), LINK has arranged the supply of an alternative product Daunorubicin (Zentiva) 20mg powder for injection vial registered and marketed in the United Kingdom. Daunorubicin (Zentiva) 20mg powder for injection vial is NOT registered in Australia and supply is authorised under an approval granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 31 July 2022.

LEUCOVORIN CALCIUM folinic acid (as calcium folinate) 50mg/5mL injection USP ampoule - shortage and alternative supply arrangement
25 May

Due to the shortage of Australian registered LEUCOVORIN CALCIUM folinic acid (as calcium folinate) 50mg/5mL injection USP ampoule (Aust R 61885), LINK has arranged the supply of an alternative product, Eurofolic folinic acid (as calcium folinate hydrate) 50mg/5mL solution for injection (vial) registered and marketed in Germany. Eurofolic folinic acid (as calcium folinate hydrate) 50mg/5mL solution for injection (vial) is NOT registered in Australia and supply is authorised under an exemption granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 29 August 2022.

EMPOVIR cidofovir 375 mg/5 mL concentrated injection for infusion vials – shortage and alternative supply arrangement
24 May

ORSPEC Pharma advises that due to the shortage of the Australian registered EMPOVIR cidofovir 375 mg/5 mL concentrated injection for infusion vials (AUST R: 287040) ORSEPC Pharma has arranged the supply of an alternative product on a temporary basis. Cidofovir Injection USP 375mg/5ml vials, are NOT registered in Australia and supply is granted under an approval granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 31 July 2022.

BENPEN benzylpenicillin (as sodium) 3 g and 1.2 g powder for injection vial – change in supply status
18 May

Pro Pharmaceuticals Group (ProPG) advises that due to a shortage of Australian registered BENPEN benzylpenicillin (as sodium) 3g and 1.2g powder for injection vial, AUST R: 10326. ProPG has arranged for an alternative product Benzylpenicillin sodium 1200 mg powder for injection (Genus Pharmaceuticals). The S19A product is registered and marketed in the UK and the supply is authorized under an exemption granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 31 July 2022.

SEPTRIN sugar-free oral liquid, trimethoprim 40 mg/5 mL and sulfamethoxazole 200 mg/5 mL, 100 mL bottle – shortage and alternative supply arrangement
11 May

LINK advises that due to the shortage of Australian registered SEPTRIN sugar-free oral liquid, trimethoprim 40 mg/5 mL and sulfamethoxazole 200 mg/5 mL, 100 mL bottle (AUST R 11000), LINK has arranged the supply of an alternative product, Co-Trimoxazole 40 mg/200 mg per 5 ml Paediatric Suspension (Aspen) registered and marketed in the United Kingdom.

DBL heparin sodium 5000 iu/0.2 ml ampoule – shortage and alternative supply arrangement
5 May

INK advises that due to a shortage of the Australian registered DBL heaparin sodium (porcine mucous) 5000 IU/0.2mL injection BP ampoule (AUST R 16349), LINK has arranged the supply of an alternative product. LINK can supply Heparin-Natrium-5000-ratiopharm, heparin sodium 5000 IU/0.2 mL ampoules registered and marketed in Germany. This product is also from porcine intestinal mucosa origin.

Sulfamethoxazole 400 mg and trimethoprim 80 mg concentrate injection ampoule – shortage and alternate supply notice
27 April

LINK advises that due to a shortage of the Australian registered DBL™ Sulfamethoxazole 400 MG and trimethoprim 80 mg concentrate injectioN BP, 5 mL ampoules (AUST R 16293), LINK has arranged the supply of an alternative product. LINK can supply Co-Trimoxazole 16 mg/80 mg per mL for Infusion (80 mg trimethoprim/400 mg sulfamethoxazole per 5 mL ampoules), registered and marketed in the United Kingdom.

Clozapine – Product Information and Consumer Medicine Information updated
22 April

The TGA has advised that the Product Information (PI) and Consumer Medicine Information (CMI) for clozapine have been updated to strengthen warnings about potential severe gastrointestinal side effects, including constipation. To 1 March 2022, there were 1,523 reports of gastrointestinal disorder for clozapine in the TGA’s Database of Adverse Event Notifications (DAEN), which included 260 reports of constipation, 146 of intestinal obstruction, 93 of abdominal pain and 41 of small intestinal obstruction. Of the 1,023 clozapine reports with a fatal outcome, 103 were due to gastrointestinal disorders.

TOFRANIL 25 imipramine hydrochloride 25 mg tablet blister pack – shortage and alternative supply arrangement
14 April

Pro Pharmaceuticals Group (ProPG) has advised that due to a shortage of Australian registered TOFRANIL 25 imipramine hydrochloride 25mg tablet blister pack, AUST R: 60673, they have arranged for an alternative product Imipramine Hydrochloride Tablets, USP, 25 mg 100 tablets (Leading Pharma, LLC) registered and marketed in the USA. The S19A USA product is identical in active ingredient, strength and form to the Australian registered products.

Herzuma trastuzumag (rch) 440 mg powder for intravenous infusion – advice of new PBS listing
1 April

Celltrion advises that Herzuma trastuzumag (rch) 440 mg powder for intravenous infusion is now available.

Min-I-Jet Atropine Sulphate 1 mg/ 10mL injection syringe vial – discontinuation and alternative supply arrangement
31 March

LINK advises that due to the discontinuation, in 2015, of the Australian registered Min-I-Jet Atropine Sulphate 1 mg/10 mL injection syringe vial, they have arranged the supply of an alternative product, atrophine sulfate 1 mg/5 mL, solution for injection in pre-filled syringe (Laboratoire Aguettant) (5 mL pre-filled syringe in pack sizes of 1 or 10).

QLAIRA estradiol valerate/dienogest tablets composite pack – shortage and alternative supply notice
29 March

LINK advises that due to a shortage of Australian registered QLAIRA estradiol valerate/dienogest tablets composite pack (AUST R 149319), they have arranged the supply of an alternative product, QLAIRA estradiol valerate/dienogest film coated tablets composite pack in wallet pack (Jenapharm GmbH Germany), registered and marketed in Germany.

Mysoline primidone 250 mg tablet bottle – notice of supply resolution and stock availability
March

Link has advised the shortage of mysoline primidone 250 mg tablet bottles has been resolved and and stock is now available in Australia.

Orencia abatacept (rch) 125 mg single dose ClickJect prefilled autoinjector – shortage and alternative supply arrangement
18 March

Link advises that due to a shortage of Australian registered ORENCIA abatacept (rch) 125 mg single dose ClickJect prefilled autoinjector (AUST R 236039) they have arranged the supply of an alternative product, Orencia 125 mg solution for injection in pre-filled pen (ClickJect) registered and marketed in Germany. The s19A approved German product is identical in active ingredient, strength and excipient ingredients to the Australian registered product.

OGIVRI brand trastuzumab 150 mg – update on alternative supply
10 March

Celltrion Healthcare Australia Pty Ltd advises they have confirmed that adequate stocks of Herzuma brand trastuzumab 150 mg are available for supply to hospital to minimise any impact to patient care, with this important oncology medication.

CeeNU lomustine 40 mg capsules – notice of shortage and alternative supply arrangements
4 March

LINK advises that due to the shortage of Australian registered CeeNU lomustine 40 mg capsules (Aust R 19249), LINK has arranged the supply of an alternative product, Cecenu lomustine 40 mg capsules (Medac) registered and marketed in Germany. Cecenu lomustine 40 mg capsules (Medac) is not registered in Australia and supply is authorised under an exemption granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 31 May 2022.

Yervoy (Ipilimumab) and Opdivo (Nivolumab) supply shortages + resolutions
25 February

Bristol-Myers Squibb Australia Pty Ltd (BMS) has provided an update regarding supply shortages resolutions for Yervoy (Ipilimumab) and Opdivo (Nivolumab).

EleCare, Similac and Alimentum – notice of precautionary recall
20 February

A number of health authorities (Victorian, NSW, SA and NT) have advised that EleCare, Similac and Alimentum infant formula products manufactured in United States are subject to a precautionary recall. The recall is due to potential microbial contamination with Salmonella Newport (Salmonella) or Cronobacter sakazakii (Cronobacter).

Lomustine – notice of out of stock
16 February

Bristol-Myers Squibb Australia Pty Ltd (BMS) advised that Ceenu (lomustine) 40 mg and 10 mg will be out of stock. BMS expects to replenish stock by late April.

Yervoy (Ipilimumab) and Opdivo (Nivolumab) supply shortages – update
11 February

Bristol-Myers Squibb Australia Pty Ltd (BMS) has provided an update regarding supply shortages resolutions for Yervoy (Ipilimumab) and Opdivo (Nivolumab).

Shortage of abatacept (Orencia)
9 February

The TGA has been advised of shortages of multiple presentations of abatacept (Orencia) products due to manufacturing delays. To assist with timely access for patients using subcutaneous formulations of abatacept (Orencia) the TGA has made a Serious Scarcity Substitution Instrument (SSSI). This SSSI declares the following as scarce and substitutable medicines, making the medicines effectively interchangeable at the pharmacy level:

  • ORENCIA abatacept (rch) 125 mg single dose syringe subcutaneous injection ultrasafe passive needle guard and flange extender (AUST R: 206764)
  • ORENCIA abatacept (rch) 125 mg single dose ClickJect prefilled autoinjector (AUST R: 236039)

Both Orencia products are in short supply and have limited availability. The SSSI is in force from 9 February 2022 until 30 April 2022. For more information see the Orencia abatacept SSSI and Substitution instrument to address shortage of abatacept (Orencia).

Shortage of DBL Heparin sodium 5000IU/1mL injection BP ampoule
8 February

LINK advises that due to the shortage of Australian registered DBL HEPARIN SODIUM 5000IU/1mL (porcine mucous) injection BP ampoule (AUST R: 12881) , LINK has arranged the supply of an alternative product, Heparin Sodium Injection, USP 5000 Units/mL solution (McKesson/Sky) registered and marketed in the USA. Heparin Sodium Injection, USP 5000 Units/mL solution (McKesson/Sky) is NOT registered in Australia and supply is authorised under an approval granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 31 March 2022

Provisional approval of molnupiravir for COVID-19
1 February

Following provisional approval for the treatment of COVID-19 in adults, the Australian Government has secured an advanced purchase agreement for 300,000 courses of Lagevrio (molnupiravir) for supply in 2022, with the first deliveries of the medicines anticipated in the coming weeks. Lagrevrio has provisional approval for the treatment of adults with COVID-19 who do not require initiation of oxygen due to COVID-19 and who are at increased risk for hospitalisation or death.

Shortage of xylocaine 2% with adrenaline 1:200,000 20 mL injection vial
1 February

Pro Pharmaceuticals Group (PPG) advises of the change in supply status of xylocaine 2% with adrenaline 1:200,000 20 mL injection vial in Australia. The Australian registered medicine, xylocaine 2% with adrenaline 1:200,000 20 mL injection vial AUST R: 12021 Active ingredients: adrenaline (epinephrine) acid tartrate lidocaine (lignocaine) hydrochloride Dosage form: Injection, solution Sponsor: Aspen Pharmacare Australia Pty Ltd is currently in shortage due to manufacturing issues. PPG has arranged for the supply of an alternative product, xylocaine 2% with epinephrine 1:200,000–lidocaine hydrochloride and epinephrine injection USP 20mL single use vial (Aspen Canada). This product is NOT registered in Australia and supply is authorised under an exemption granted by the TGA under section 19A of the Therapeutic Goods Act 1989 until 30 November 2022.

Notification of out-of-stock period for opdivo (nivolumab) 100 mg/10 ml and 40 mg/4 ml vials concentrate solution for intravenous infusion
31 January

Bristol-Myers Squibb Australia Pty Ltd (BMS) advises that from the end of February (anticipated week commencing 28 February 2022), the Opdivo (Nivolumab) 40 mg /4 mL vial concentrate solution for intravenous infusion will be out of stock in Australia and not available. BMS anticipates this situation will last 3–4 weeks. Assuming an increased demand, they anticipate from early March (week commencing 7 March) Opdivo (Nivolumab) 100 mg /10 mL vial concentrate solution for intravenous infusion will also be out of stock in Australia and not available. BMS anticipates this situation will last 2–3 weeks.

Shortage of shortage of navelbine vinorelbine tartrate 50 mg/5 mL and 10 mg/mL and alternative supply arrangement
29 January

LINK advises that due to the shortage of Australian registered NAVELBINE vinorelbine tartrate 50 mg/5 mL (AUST R 62248) and NAVELBINE vinorelbine tartrate 10mg/mL (AUST R 62246), LINK has arranged the supply of an alternative product, Vinorelbine Injection USP (Sagent) registered and marketed in the USA. This product is available in both a 10 mg/mL injection and a 50 mg/5 mL injection. Vinorelbine Injection USP (Sagent) is NOT registered in Australia and supply is authorised under an exemption granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 31 May 2022.

Shortage of sulfamethoxazole 400 mg and trimethoprim 80 mg concentrate injection ampoule and alternative supply arrangement
27 January

LINK advises that due to a shortage of the Australian registered DBL™ sulfamethoxazole 400 MG and trimethoprim 80 MG concentrate injection BP, 5 mL ampoules (AUST R 16293), LINK has arranged the supply of an alternative product. LINK can supply Co-Trimoxazole 16 mg/80 mg per mL for infusion (80 mg trimethoprim/400 mg sulfamethoxazole per 5 mL ampoules), registered and marketed in the UK.

Notice of out-of-stock period for yervoy (ipilimumab) 200 MG/40 ML and 50 MG/10 ML vials concentrate solution for intravenous infusion
27 January

Bristol-Myers Squibb Australia Pty Ltd (BMS) has provided a further update to their correspondence on 11 January regarding the Yervoy (Ipilimumab) out of stock period: The out-of-stock period for Yervoy (Ipilimumab) 200 mg /40 mL vial concentrate solution forintravenous infusion is no longer anticipated, it is current as of 14 January. The out-of-stock period has been revised from 3–4 weeks and is now anticipated to last 8 weeks. From 1 February 2022 BMS anticipates Yervoy (Ipilimumab) 50 mg /10 mL vial concentrate solution for intravenous infusion will also be out of stock in Australia and not available. This situation is anticipated to last 2 weeks.

Shortage of oncotice BCG 5 hundred million CFU powder for injection vial and alternative supply arrangement
25 January

LINK advises that due to the shortage of the Australian registered ONCOTICE BCG 5 hundred million CFU powder for injection vial (AUST R 59912), LINK has arranged the supply of an alternative product. LINK can supply BCG Culture SSI BCG 30 mg/vial (AJ Vaccines). BCG Culture SSI BCG 30 mg/vial (AJ Vaccines) is NOT registered in Australia and supply is authorised under an exemption granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 31 January 2024.

Restored normal supply of AmBisome® (liposomal amphotericin), 50 mg powder for injection
18 January 2022

An update on product defect correction (TGA Ref: RC-2021-RN-00379-1): Subsequent to the above-mentioned product defect correction related to Sartorius Minisart® 5 μm sterile filters (17594-GJR) present in cartons of AmBisome 50 mg powder for injection (AUST R 53783), Gilead is pleased to advise that normal supply of AmBisome packaged with unimpacted filters will recommence from late January 2022.

Resupply of Zerbaxa® (ceftolozane sulfate/tazobactam sodium 1000 mg/500 mg powder for injection)
18 January

Merck Sharp & Dohme (Australia) Pty Ltd has advised they expect Zerbaxa® (ceftolozane/tazobactam) will be available again in Australia in early March 2022.

Notification of out-of-stock period for yeryoy (ipilimumab) 200 mg/40 ml vial concentrate solution for intravenous infusion
12 January

Bristol-Myers Squibb Australia Pty Ltd advises that from the end of January 2022 (anticipated, week commencing 24 January 2022), the Yervoy (Ipilimumab) 200 mg vial/40mL vial concentrate solution for intravenous infusion will be out of stock in Australia and not available. This situation is anticipated to last 3–4 weeks.

Availability of slow-release potassium citrate
13 December

ORSPEC Pharma Pty Ltd advises that slow-release potassium citrate is now available commercially in Australia.

TGA Provisional Approval of COVID-19 treatment regdanvimab (REGKIRONA)
6 December

Celltrion has advised that the TGA has granted provisional approval for the use of regdanvimab (REGKIRONA) for the treatment of COVID-19. This is the fifth COVID-19 treatment to receive regulatory approval in Australia. This monoclonal antibody treatment is now provisionally approved for the intravenous treatment of mild-to-moderate COVID-19 in adult patients who are confirmed to be infected with the SARS-CoV-2 virus.

Shortage of APO-Dutasteride 500 mcg capsules and alternative supply arrangement
6 December

LINK advises that due to the shortage of Australian registered APO-Dutasteride 500 .mcg Capsules (AustR 212047). LINK has arranged the supply of an alternative product, Dutasteride 0.5 mg capsules (Camber) registered and marketed in the USA. Dutasteride 0.5 mg capsules (Camber) is NOT registered in Australia and supply is authorised under an exemption granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 30 April 2022.

Discontinuation of DBL GENTAMICIN 10mg/1mL (as sulfate) injection BP ampoule and alternative supply arrangement
6 December 

LINK advises that due the discontinuation of Australian registered DBL GENTAMICIN 10 mg/1 mL (as sulfate) injection BP ampoule (AUST R 16339), LINK has arranged the supply of an alternative product. LINK can supply GENTAMICIN INJECTION USP 10 mg/mL (20 mg/2 mL) (Teligent OU), registered and marketed in Canada. GENTAMICIN INJECTION USP 10 mg/mL (20 mg/2 mL) (Teligent OU) is NOT registered in Australia and supply is granted under an exemption granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 30 November 2022.

Availability of THIOTEPA FOR INJECTION, USP 15 mg/VIAL (NOVADOZ) and THIOTEPA FOR INJECTION, USP 100 mg/VIAL (NOVADOZ)
3 December 2021

Reach Pharmaceuticals Pty Ltd advises they have received approval to supply THIOTEPA FOR INJECTION, USP 15 mg/VIAL and THIOTEPA FOR INJECTION, USP 100 mg/VIAL through early access to a medicine under evaluation for inclusion in the ARTG – subsection 19A(2) of the Therapeutic Goods Act 1989.

Calcium Gluconate Injection: New formulation
30 November

Phebra has advised of a change of formulation of Calcium Gluconate Injection. The calcium ion concentration remains equivalent to the previous formulation, i.e. 2.2 millimoles of calcium ions or 4.4 mEq of calcium ions in 10 mL. The amounts of calcium gluconate and calcium saccharate have been modified to improve the formulation.

TEPADINA thiotepa 15 mg and 100 mg vial supply arrangement
11 November

LINK advises that due to lack of the Australian registered thiotepa for injection thiotepa 15 mg powder for injection vial (AUST R 43083), LINK have arranged the supply of the following alternative products: 1) Tepadina thiotepa 15 mg powder for concentrate for solution for infusion (UK); and 2) Tepadina thiotepa 100 mg powder for concentrate for solution for infusion (UK). These products are registered in the European Union and marketed in the UK.

Shortage of Mysoline Primidone 250 mg Tablets
4 November

LINK advises that due to the shortage of Australian registered Mysoline primidone 250 mg tablet bottle (AUST R 11231), LINK has arranged the supply of an alternative product, Primidone 250 mg USP Tablets (Lannett) registered and marketed in the USA. Primidone 250 mg USP Tablets (Lannett) is NOT registered in Australia and supply is authorised under an exemption granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 31 March 2022.

Confirmation of adequate stock availability of Truxima® brand biosimilar rituximab in Australia
5 November

Following the PBAC’s September 21 intra-cycle meeting in which it was recommended that the PBS listings for all listed brands of rituximab be changed to Unrestricted Benefit listings, Celltrion Healthcare has confirmed adequate stock availability of Truxima® brand biosimilar rituximab in Australia.

Shortage of DBL HEPARIN SODIUM 5000 IU/1 mL (porcine mucous) injection BP ampoule (AUST R: 12881) and alternative supply arrangement
4 November

LINK advises that due to the shortage of Australian registered DBL HEPARIN SODIUM 5000IU/1mL (porcine mucous) injection BP ampoule (AUST R: 12881) , they have arranged the supply of an alternative product, Heparin Sodium Injection, USP 5000 Units/mL solution (McKesson/Sky) registered and marketed in the USA. Heparin Sodium Injection, USP 5000 Units/mL solution (McKesson/Sky) is not registered in Australia and supply is authorised under an approval granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 31 January 2022.

Discontinuation of DILAUDID hydromorphone hydrochloride 1 mg/mL oral liquid bottle and alternative supply arrangement
2 November

LINK advises that DILAUDID hydromorphone hydrochloride 1 mg/mL oral liquid bottle (AUST R 67360) sponsored by Mundipharma Pty Ltd has been discontinued. LINK has arranged the supply of an alternative product, HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION 1 mg/mL USP 473mL (Hikma) registered and marketed in the United States. This product is NOT registered in Australia and supply is authorised under an approval granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 31 August 2022.

Supply arrangement for Cipla Isoproterenol (isoprenaline hydrochloride) 0.2 mg/1 mL and 1 mg/5 mL solution for injection ampoule
22 October

Reach Pharmaceuticals has advised they have received approval to supply Cipla Isoproterenol (isoprenaline hydrochloride) 0.2 mg/1 mL solution for injection ampoule (Reach Pharmaceuticals) and Cipla Isoproterenol (isoprenaline hydrochloride) 1 mg/5 mL solution for injection ampoule (Reach Pharmaceuticals) under the early access to a medicine under evaluation for inclusion in the ARTG – subsection 19A(2). Cipla Isoproterenol (isoprenaline hydrochloride) 0.2 mg/1 mL solution for injection ampoule (Reach Pharmaceuticals) and Cipla Isoproterenol (isoprenaline hydrochloride) 1 mg/5 mL solution for injection ampoule (Reach Pharmaceuticals) are currently under evaluation by the TGA and supply is authorised under an exemption granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 30 April 2022. The US FDA approved packs will be supplied in Australia.

Shortage of Supply of Reyataz (atazanavir) 300 mg
14 October

Bristol Myers Squibb (BMS) has advised there will be an anticipated stock shortage of Reyataz 300 mg from mid-November through to mid-December 2021. The TGA has been notified. The next delivery of Reyataz 300 mg is expected by 20 Dec 2021, however this date is subject to change. BMS is committed to resupplying this medicine to the market as soon as possible.

Shortage of Nimbex cisatracurium (as besilate) 5 mg/2.5 mL (2 mg/mL) injection ampoule and alternative supply arrangments
7 October

LINK has advised that due to the shortage of Australian registered NIMBEX cisatracurium (as besilate) 5 mg/2.5 mL (2 mg/mL) injection ampoule (Aust R 55913), LINK has arranged the supply of an alternative product, Cisatracurium-hameln 2mg/mL Solution for Injection/Infusion registered and marketed in Germany. This product is available in both 5 mg/2.5 mL and 10 mg/5 mL ampoules. Cisatracurium-hameln 2 mg/mL Solution for Injection/Infusion 5 mg/2.5 mL and 10 mg/5 mL ampoules are NOT registered in Australia and supply is authorised under an exemption granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 31 March 2022.

Shortage of DBL ACETYLCYSTEINE, injection concentrate acetylcysteine 2 g/ 10 mL ampoule product and alternative supply arrangement
27 September

ORSPEC Pharma advises that due to the shortage of DBL ACETYLCYSTEINE injection concentrate acetylcysteine 2 g/ 10 mL injection ampoule (AUST R 121503). ORSEPC Pharma has arranged the supply of an alternative product on a temporary basis. ACETYLCYSTEINE SOLUTION USP 2000mg/10mL (200mg/mL), are not registered in Australia and supply is granted under an exemption granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 31 December 2021.

Notice of approval s19A(1) RoActemra tocilizumab 162 mg 0.9mL solution for injection filled syringe and pen
22 September

Pro Pharmaceuticals Group has shared a Notice of approval for the importation and supply of specified therapeutic goods This notice refers to the application made under section 19A of the Therapeutic Goods Act 1989 (the Act) dated 7 September 2021 in relation to:

  • RoActemra tocilizumab 162 mg/0.9 mL solution for injection in pre-filled syringe (Roche Germany)
  • RoActemra tocilizumab 162 mg/0.9 mL solution for injection in pre-filled pen (Roche Germany)

Notice of approval s19A(1) RoActemra tocilizumab concentrate for injection vials
13 September

Pro Pharmaceuticals Group has shared a Notice of approval for the importation and supply of specified therapeutic goods This notice refers to the application made under section 19A of the Therapeutic Goods Act 1989 (the Act) dated 6 September 2021 in relation to:

  • RoActemra tocilizumab 80 mg/4 mL concentrate for solution for infusion (Roche Germany)
  • RoActemra tocilizumab 200 mg/10 mL concentrate for solution for infusion (Roche Germany)
  • RoActemra tocilizumab 400 mg/20 mL concentrate for solution for infusion (Roche Germany)

Discontinuation of Min-I-Jet Atropine Sulphate 1 mg/10 mL injection syringe vial (ARTG 48529) (in April 2015) and alternative supply arrangement
13 September

LINK advises that due to the shortage and subsequent discontinuation, in 2015, of the Australian registered Min-I-Jet Atropine Sulphate 1 mg/10 mL injection syringe vial (ARTG 48529), LINK has arranged the supply of an alternative product, Atropine Sulfate 1 mg/5 mL, solution for injection in pre-filled syringe (Laboratoire Aguettant) (5 mL pre-filled syringe in pack sizes of 1 or 10) on a temporary basis.

Shortage of navelbine vinorelbine tartrate 50 mg/5 mL and navelbine vinorelbine tartrate 10 mg/mL and alternative supply arrangement
13 September

LINK advises that due to the shortage of Australian registered navelbine vinorelbine tartrate 50 mg/5 mL (AUST R 62248) and NAVELBINE vinorelbine tartrate 10 mg/mL (AUST R 62246), LINK has arranged the supply of an alternative product, Vinorelbine Injection USP (Sagent) registered and marketed in the USA. This product is available in both a 10 mg/mL injection and a 50 mg/5 mL injection. Vinorelbine Injection USP (Sagent) is not registered in Australia and supply is authorised under an exemption granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 31 January 2022.

Shortage of ATENOLOL-AFT atenolol 50 mg/10 mL oral solution bottle and alternative supply arrangement
1 September

LINK advises that due to a shortage of Australian registered ATENOLOL-AFT atenolol 50 mg/10 mL oral solution bottle (AUST R 184745), LINK has arranged the supply of an alternative product. LINK can supply Atenolol 25 mg/5 ml Sugar Free Oral Solution (Essential Generics), registered and marketed in the UK. Atenolol 25 mg/5 ml Sugar Free Oral Solution (Essential Generics) is not registered in Australia and supply is granted under an exemption granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 30 November 2021.

Discontinuation of DILAUDID hydromorphone hydrochloride 1mg/mL oral liquid bottle and alternative supply arrangement
31 August

LINK advises the Australian registered medicine, dilaudid hydromorphone hydrochloride 1mg/mL oral liquid bottle (AUST R 67360) sponsored by Mundipharma Pty Ltd has been discontinued. LINK has arranged the supply of an alternative product, hydromorphone hydrochloride oral solution 1 mg/mL USP 473 mL (West-Ward) registered and marketed in the United States. This product is not registered in Australia and supply is authorised under an approval granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 31 August 2022.

Shortage of heparin sodium 25000 IU/5 mL (porcine mucous) injection ampoule and alternative supply arrangement
25 August

ORSPEC Pharma advises that due to the shortage of HEPARIN SODIUM 25000 IU/5 mL (porcine mucous) injection ampoule, (AUST R 49236). ORSEPC Pharma has arranged the supply of an alternative product on a temporary basis. WOCKHARDT Heparin Sodium (5,000 IU/ml) 25,000 units in 5 ml solution for injection or concentrate for solution for infusion, is not registered in Australia and supply is authorised under an approval granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 08 November 2021.

Shortages of tocilizumab (Actemra) medicines
4 August

On 21 July 2021, Roche Products Pty Limited (Roche), the sponsor of tocilizumab (Actemra), notified the Therapeutic Goods Administration (TGA) of shortages of multiple presentations of tocilizumab (Actemra) products due to global demand in response to the COVID-19 pandemic. On 4 August the TGA published a joint statement with the Australian Rheumatology Association and Arthritis Australia providing clinical guidelines to help health professionals manage this shortage, as well as further information for consumers.

Shortage of sulfamethoxazole 400 mg and trimethoprim 80 mg concentrate injection ampoule and alternative supply arrangement
27 July

LINK advises that due to a shortage of the Australian registered DBL™ sulfamethoxazole 400 mg and trimethoprim 80 mg concentrate injection BP, 5 mL ampoules (AUST R 16293), LINK has arranged the supply of an alternative product. LINK can supply Co-Trimoxazole 16 mg/80 mg per mL for Infusion (80 mg trimethoprim/400 mg sulfamethoxazole per 5 mL ampoules), registered and marketed in the UK. Co-Trimoxazole 16 mg/80 mg per mL for Infusion are not registered in Australia and supply is granted under an exemption granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 31 January 2022.

Shortage of DBL GENTAMICIN 10 mg/1 mL (as sulfate) injection BP ampoule and alternative supply arrangement
28 July

LINK has advised that due to a shortage of Australian registered DBL Gentamicin 10mg/1mL (as sulfate) injection BP ampoule (AUST R 16339), LINK has arranged the supply of an alternative product. LINK can supply Gentamicin injection USP 10mg/mL (20 mg/2mL) (Teligent OU), registered and marketed in Canada. Gentamicin injection USP 10 mg/mL (20 mg/2 mL) (Teligent OU) is NOT registered in Australia and supply is granted under an exemption granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 05 December 2021.

Recall notice: Philips medical breathing support devices
22 July

Electronics manufacturer, Philips, has announced a product defect correction for a range of medical breathing support devices due to concerns about potential defects. The TGA is working with Philips to ensure the product defect correction is conducted quickly and safely. The TGA has advised that devices currently in use in critical or lifesaving situations should continue to be used until an alternative becomes available.

Shortages of tocilizumab (Actemra) medicines
21 July

Roche Products Pty Limited (Roche), the sponsor of tocilizumab (Actemra), has notified the TGA of shortages of multiple presentations of tocilizumab (Actemra) products due to global demand in response to the COVID-19 pandemic. Actemra 200mg intravenous (IV) injection is currently in shortage until the end of August 2021.

Reyataz atazanavir (as sulfate) 300 mg capsule bottle: Product defect alert
20 July

Following consultation with the TGA, Bristol-Myers Squibb Australia Pty Ltd is undertaking a product defect alert of the above product. Bottle label for Reyataz 300mg, AUST R 134967, does not contain the statement for lactose as required in Therapeutic Goods Order (TGO) No. 91 – Standard for labels of prescription and related medicines. Statement that should be stated on the label is ‘contains sugars as lactose’. A TGA exemption application to continue to supply Reyataz 300 mg without the lactose statement is under review by the TGA.

Infliximab subcutaneous is PBS listed for pre-filled pen and pre-filled syringe
1 July

Celltrion Healthcare Australia advised that Remsima® (infliximab) subcutaneous is PBS listed for pre-filled pen and pre-filled syringe.

Shortage of Supply of Reyataz (atazanavir) 300 mg
25 June

Bristol Myers Squibb (BMS) advises there is currently a stock shortage of Reyataz 300 mg. The  shortage of Reyataz 300 mg is due to updated labeling requirements. The next delivery of Reyataz 300 mg is expected by 30 October 2021, however this date is subject to change. BMS is committed to resupplying this medicine to the market as soon as possible.

Shortage of ATENOLOL-AFT atenolol 50 mg/10 mL oral solution bottle (AUST R 184745), and alternative supply arrangement
1 June

LINK has advised that due to a shortage of Australian registered ATENOLOl-AFT atenolol 50 mg/10 mL oral solution bottle (AUST R 184745), LINK has arranged the supply of an alternative product. LINK can supply Atenolol 25 mg/5 ml Sugar Free Oral Solution (Essential Generics), registered and marketed in the UK. Atenolol 25 mg/5 ml Sugar Free Oral Solution (Essential Generics) is not registered in Australia and supply is granted under an exemption granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 31 August 2021.

Shortage of MYSOLINE 250 mg tablets and alternative supply arrangement
24 May

LINK has advised that due to a shortage of the Australian registered MYSOLINE primidone 250 mg tablet bottle (AUST R 11231), LINK has arranged the supply of the alternative product: APO-Primidone 250 mg tablets (New Zealand), registered and marketed in New Zealand. APO-Primidone 250mg tablets (New Zealand) are not registered in Australia and supply is granted under an exemption granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 28 February 2022.

Shortage of QLAIRA estradiol valerate/dienogest tablets composite pack and alternative supply arrangement
21 May

LINK advises that due to a shortage of Australian registered QLAIRA estradiol valerate/dienogest tablets composite pack (AUST R 149319), LINK has arranged the supply of an alternative product: QLAIRA estradiol valerate/dienogest film coated tablets composite pack in wallet pack (Bayer Limited Ireland), registered and marketed in Ireland. QLAIRA estradiol valerate/dienogest film coated tablets composite pack in wallet pack (Bayer Limited Ireland), is not registered in Australia and supply is granted under an exemption granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 31 July 2022.

Shortage of tofranil 10 imipramine hydrochloride 10 mg tablet blister pack and alternative supply arrangement
14 May

Pro Pharmaceuticals Group Pty Ltd advises that imipramine 10 mg tablets will soon be available as S19A until 31 August 2021 due to shortage of Tofranil 10 mg (imipramine) (AUST R 11064), in Australia. This product is not registered in Australia and supply is authorised under an approval granted by the Therapeutic Goods Administration (TGA) under section 19A of the Therapeutic Goods Act 1989 until 31 August 2021.

Shortage of SPAN K potassium chloride 600 mg tablet bottle and alternative supply
13 May

Link Medical Products has advised the Australian registered medicine, SPAN K potassium chloride 600 mg tablet bottle (new formulation) (AUST R 328843), sponsored by Aspen Pharmacare Australia is in short supply. The shortage of SPAN K is expected to be resolved 30 September 2021. Link Medical Products has been able to arrange supply of an alternative product, EURO-K 600 Potassium Chloride 600mg Sustained Release Tablets USP, 100 tablet bottle (Euro-Pharm) on a temporary basis. This product is not registered in Australia and supply is granted under an exemption granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act 1989 until 31 October 2021.

Shortage of clexane enoxaparin and alternative supply arrangement
7 May

ORSPEC Pharma advises that due to the shortage of CLEXANE, Enoxaparin 20 mg/0.2 mL and 40 mg/0.4 mL injection syringe products (AUST R 221717 and AUST R 221718), they have arranged the supply of an alternative product on a temporary basis. Inhixa 2,000 IU (20 mg)/0.2 mL and Inhixa 4,000 IU (40 mg)/0.4 mL solution for injection, are not registered in Australia and supply is granted under an exemption granted by the TGA under Section 19A of the Therapeutic Goods Act, 1989 until 7 July 2021.

Shortage of Adrenaline 1:1,000 (1 mg/1 mL) ampoules and alternative supply arrangement
29 April

LINK has advised that due to the shortage of Australian registered Adrenaline-LINK 1:1,000 1mg/mL adrenaline (epinephrine) acid tartrate injection BP ampoule (AUST R 12048), they have arranged the supply of an alternative product, Adrenaline Renaudin, adrenaline 1 mg/mL solution for injection 1 mL ampoule, registered and marketed in France. Adrenaline Renaudin 1 mg/mL ampoules are not registered in Australia and supply is authorised under an exemption granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 31 October 2021.

Replacement 5 μm filters for AmBisome® (liposomal amphotericin), 50 mg powder for injection, AUST R 53783: Product defect correction
28 April 

Subsequent to the above-mentioned product defect correction related to Sartorius Minisart® 5 μm sterile filters (17594-GJR) present in cartons of AmBisome 50 mg powder for injection (AUST R 53783), Gilead has provided advance notice of changes to AmBisome outer packaging, as agreed with the TGA, as well as a filter replacement guide.

Discontinuation of the sale and distribution of CeeNU (lomustine)
19 April 

Bristol Myers Squibb has advised that the sale and distribution of CeeNU (lomustine) will be discontinued in Australia and New Zealand in December 2022. This discontinuation includes all dose strengths (10 mg and 40 mg). The decision to discontinue CeeNU is due to declining demand and the availability of newer, preferred therapies (recommended by current treatment guidelines) for the treatment of brain tumours, such as glioblastomas. As such, the decision to discontinue CeeNU is voluntary and not related to any quality, safety or efficacy issues regarding the product.

Shortage of DILAUDID hydromorphonehydrochloride 1 mg/mL oral liquid bottle (AUST R 67360) and alternate supply arrangement
7 April

Medsurge advises that the Australian registered medicine, DILAUDID hydromorphone hydrochloride 1mg/mL oral liquid bottle (AUST R 67360), sponsored by Mundipharma Pty Ltd is in short supply. Medsurge has been able to arrange for supply of alternative products HYDROmorphone Hydrochloride Oral Solution 1 mg/mL, USP 473 mL (Rhodes), registered and marketed in USA. This product is not registered in Australia and supply is authorised under an exemption granted by the Therapeutic Goods Administration (TGA) under section 19A of the Therapeutic Goods Act 1989 until 9 January 2022.

NEO‐MERCAZOLE carbimazole 5 mg tablet bottle (ARTG 194296) shortage and alternative supply arrangement
29 March

Seed Pharma Pty Ltd has advised the Australian-registered medicine, Neo‐Mercazole carbimazole 5 mg tablet bottle (ARTG 194296), sponsored by Amdipharm Mercury Australia Pty Ltd is in short supply due to manufacturing delays. Supply of NEO‐MERCAZOLE carbimazole 5 mg tablet bottle is expected to resume 30 April 2021. Seed Pharma Pty Ltd has been able to arrange supply of an alternative product Carbimazole 5mg tablets (DAWA Ltd) on a temporary basis. This product is not registered in Australia and supply is authorised under an approval granted by the TGA under section 19A of the Therapeutic Goods Act 1989 until 31 May 2021.

Discontinuation of Min-I-Jet Atropine Sulphate 1mg/10mL injection syringe vial (ARTG 48529) (in April 2015) and alternative supply arrangement
23 March

LINK advises that due to the shortage and subsequent discontinuation, in 2015, of the Australian registered Min-I-Jet Atropine Sulphate 1mg/10mL injection syringe vial (ARTG 48529), LINK has arranged the supply of an alternative product, ATROPINE SULFATE 1mg/5mL, solution for injection in pre-filled syringe (Laboratoire Aguettant) (5 mL pre-filled syringe in pack sizes of 1 or 10) on a temporary basis.

ZERBAXA ceftolozane sulfate/tazobactam sodium 1000 mg/500 mg powder for injection – global supply interruption expected to continue throughout 2021
15 March (Original notice: 23 December 2020)

MSD, following consultation with the Therapeutic Goods Administration (TGA), is conducting a recall in Australia of ZERBAXA, batches S036990 and T025455. Due to a recent manufacturing issue identified during the routine testing of ZERBAXA (ceftolozane/tazobactam), manufacturing of the product has been temporarily stopped. The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. The investigation into the source of the R. Pickettii is ongoing and the seven batches have not been released to the market.

Shortage of DBL GENTAMICIN 10 mg/1 mL (as sulfate) injection BP ampoule and alternative supply arrangement
10 March

LINK has advised that due to a shortage of Australian registered DBL GENTAMICIN 10 mg/1 mL (as sulfate) injection BP ampoule (AUST R 16339), LINK has arranged the supply of an alternative product. LINK can supply GENTAMICIN INJECTION USP 10 mg/mL (20 mg/2 mL) (Teligent OU), registered and marketed in Canada. GENTAMICIN INJECTION USP 10 mg/mL (20 mg/2 mL) (Teligent OU) is not registered in Australia and supply is granted under an exemption granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act 1989 until 31 July 2021.

Shortage of SPAN K potassium chloride 600mg tablet bottle and alternative supply arrangement
4 March

LINK advises the Australian registered medicine, SPAN K potassium chloride 600 mg tablet bottle (new formulation) (AUST R 328843), sponsored by Aspen Pharmacare Australia is in short supply. The shortage of SPAN K is expected to be resolved by 8 April 2021. Link Medical Products has been able to arrange supply of an alternative product, EURO-K 600 Potassium Chloride 600mg Sustained Release Tablets USP, 100 tablet bottle (Euro-Pharm) on a temporary basis. This product is not registered in Australia and supply is granted under an exemption granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act 1989 until 31 May 2021.

Shortage of urex forte furosemide (frusemide) 500 mg tablet blister pack and alternate supply arrangement
25 February 

The Australian registered medicine, UREX FORTE furosemide (frusemide) 500 mg tablet blister pack AUST R 196972 sponsored by Arrow Pharma Pty Ltd is unavailable. Medsurge has been able to arrange for supply of Furosemid-ratiopharm 500 mg Furosemide tablets as an alternative product on a temporary basis. This product is NOT registered in Australia and supply is authorised under an exemption granted by the Therapeutic Goods Administration (TGA) under section 19A of the Therapeutic Goods Act 1989 until 30 April 2021.

Shortage of DBL ergometrine injection, ergometrine maleate (500 mcg/mL) ampoule and alternative supply arrangement
18 February 

LINK advises that due to a shortage of the Australian registered DBL ergometrine injection, ergometrine maleate (500 mcg/mL) ampoule (AUST R 58866), LINK has arranged the supply of an alternative product. LINK can supply ergonovine maleate injection (ergonovine maleate injection, USP) 0.25 mg/mL, ampoules registered and marketed in Canada.

Notice of withdrawal of Sartorius 5µm Filters present in cartons of AmBisome®, amphotericin B, 50mg, powder for injection, AUST R 53783
11 February 

Gilead has been notified of a quality defect issue by their supplier, Sartorius, in relation to specific lots f 5µm sterile filters, which are co-packed in cartons of the AmBisome product. The filter is called Minisart® Filter 17594-GJ. Sartorius has informed Gilead that the filter lots packaged with the AmBisome batches listed in the Appendix may be releasing fibres and particles, which may pose a risk to the patient.

Shortage of Nardil phenelzine 15 mg (as sulfate) tablet bottle (AUST R 93600) and alternative supply arrangement
10 February 

The Australian registered medicine, Nardil phenelzine 15 mg (as sulfate) tablet bottle (AUST R 93600), sponsored by Link Medical Products Pty Ltd, has been discontinued from the Australian market. To address this medicine shortage, Generic Health Pty Ltd has been able to arrange supply of an alternative product, Phenelzine Sulfate USP 15 mg Tablets (Lupin Pharmaceuticals) (PBS-listed), on a temporary basis.

Rituximab: Alternative supply arrangement notice
10 February

Following Roche Pharmaceuticals Australia's market announcement indicating their decision to de-list Mabthera® (rituximab) from the Pharmaceutical Benefits Scheme (PBS) effective 1st April 2021, Celltrion Healthcare Australia has advised a number of aspects pertaining to Truxima®, a biosimilar rituximab which Celltrion supplies.

Shortage of ONCOTICE BCG 5 hundred million CFU powder for injection vial (AUST R 59912)
9 February

LINK advises that due to the shortage of the Australian registered ONCOTICE BCG 5 hundred million CFU powder for injection vial (AUST R 59912), LINK has arranged the supply of an alternative product. LINK can supply BCG Culture SSI BCG 30 mg/vial (AJ Vaccines). BCG Culture SSI BCG 30 mg/vial (AJ Vaccines) is NOT registered in Australia and supply is authorised under an exemption granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 31 January 2022.

Shortage of DBL ERGOMETRINE INJECTION, ergometrine maleate (500 mcg/mL) ampoule
9 February 

LINK has advised that due to a shortage of the Australian registered DBL ERGOMETRINE INJECTION, ergometrine maleate (500 mcg/mL) ampoule (AUST R 58866), LINK has arranged the supply of an alternative product. LINK can supply ERGONOVINE MALEATE INJECTION (ergonovine maleate injection, USP) 0.25 mg/mL, ampoules registered and marketed in Canada.

Phenelzine Sulfate USP 15 mg Tablets (Lupin Pharmaceuticals) – supply arrangement
9 February 

On 9 February, Generic Health Pty Ltd advised that the above overseas-registered product has been approved for temporary supply under the Section 19A of the Therapeutic Goods Act 1989. In response to the discontinuation of the Australian registered medicine, NARDIL phenelzine 15mg (as sulfate) tablet bottle (AUST R 93600), Generic Health Pty Ltd has been able to arrange supply of an alternative product, Phenelzine Sulfate USP 15 mg Tablets (Lupin Pharmaceuticals). See additional information here.

Shortage of the Australian registered IMOGAM RABIES PASTEURIZED human rabies immunoglobulin 150 IU/mL injection vial (AUST R 72931)
2 February 

LINK advises that due to the shortage of the Australian registered IMOGAM RABIES PASTEURIZED human rabies immunoglobulin 150 IU/mL injection vial (AUST R 72931), LINK has arranged the supply of an alternative product. LINK can supply KamRAB 150 IU/mL Solution for injection - 2 mL vial (Human Rabies immunoglobulin), registered and marketed in Israel. KamRAB 150 IU/mL Solution for injection - 2 mL vial (Human Rabies immunoglobulin) is NOT registered in Australia and supply is authorised under an exemption granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 31 January 2022.

Shortage of Adrenaline 1:1,000 (1 mg/1 mL) ampoules and alternative supply
1 February 

LINK advises that due to the shortage of Australian registered ADRENALINE-LINK 1:1,000 1mg/mL adrenaline (epinephrine) acid tartrate injection BP ampoule (AUST R 12048), LINK has arranged the supply of an alternative product, ADRENALINE RENAUDIN, adrenaline 1 mg/mL solution for injection 1 mL ampoule, registered and marketed in France. ADRENALINE RENAUDIN 1 mg/mL ampoules are NOT registered in Australia and supply is authorised under an exemption granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 30 April 2021.

Shortage of MINIRIN desmopressin acetate 10 microgram/actuation nasal spray and alternate supply arrangement
29 January

The Australian registered medicine, MINIRIN desmopressin acetate 10 microgram/actuation nasal spray (AUST R 59320) sponsored by Ferring Pharmaceuticals Pty Ltd is unavailable due to product recall. Medsurge has been able to arrange for the supply of Desmopressin Acetate Nasal Spray 10mcg/0.1mL (Apotex) as an alternative product on a temporary basis. This product is NOT registered in Australia and supply is authorised under an exemption granted by the Therapeutic Goods Administration (TGA) under section 19A of the Therapeutic Goods Act 1989 until 31 January 2022.

Shortage of NEO-MERCAZOLE carbimazole 5mg tablet bottle ARTG 194296 and alternate supply arrangement
29 January

Medsurge advises the Australian registered medicine NEO-MERCAZOLE carbimazole 5 mg tablet bottle ARTG 194296 sponsored by Amdipharm Mercury Australia Pty Ltd is unavailable due to manufacturing delays. Supply of NEO-MERCAZOLE carbimazole 5 mg tablet bottle ARTG 194296 is expected to resume 28 February 2021. Medsurge has been able to arrange for supply of Carbimazole 5 mg tablets (Morningside Health) as an alternative product on a temporary basis. This product is NOT registered in Australia and supply is authorised under an exemption granted by the Therapeutic Goods Administration (TGA) under section 19A of the Therapeutic Goods Act 1989 until 31 March 2021.

Shortage of DIASP SR Dipyridamole/Aspirin 200 mg/25 mg modified release capsules bottle and ASASANTIN SR dipyridamole 200mg/aspirin 25mg sustained release capsule bottle
29 January

Medsurge advises the Australian registered medicine ASASANTIN SR dipyridamole 200mg/aspirin 25mg sustained release capsule bottle AUST R 68051 sponsored by Boehringer Ingelheim Pty Ltd has been discontinued. The Australian registered medicine DIASP SR Dipyridamole/Aspirin 200 mg/25 mg modified release capsules bottle AUST R 210808 sponsored by Arrow Pharma Pty Ltd is unavailable due to unexpected increase in demand. Medsurge has been able to arrange for the supply of Aspirin and Extended-release Dipyridamole Capsules 25mg/200mg (USA) as an alternative product on a temporary basis. This product is NOT registered in Australia and supply is authorised under an exemption granted by the Therapeutic Goods Administration (TGA) under section 19A of the Therapeutic Goods Act 1989 until 31 August 2021.

Shortage of CYKLOKAPRON tranexamic acid 500mg tablet bottle and alternate supply arrangement
29 January

Medsurge advises the Australian registered medicine, CYKLOKAPRON tranexamic acid 500mg tablet bottle (AUST R 14463), sponsored by Pfizer Australia Pty Ltd is in short supply due to unexpected increase in demand. Medsurge has been able to arrange for supply of an alternative product, Tranexamic acid 500mg tablets (TILLOMED) 60 tablets, on a temporary basis. This product is NOT registered in Australia and supply is authorised under an exemption granted by the Therapeutic Goods Administration (TGA) under section 19A of the Therapeutic Goods Act 1989 until 31 May 2021.

Shortage of DBL Ergometrine Injection
29 January 

The Department of Health advises that an upcoming shortage of DBL Ergometrine Injection (AUST R 58866) from 12 February 2021 until 18 June 2021. Ergometrine is used in the hospital setting during obstetric procedures following the delivery of the placenta to promote involution of the uterus in order to treat haemorrhage. The alternative product, Ergonovine maleate injection USP (0.25 mg/mL) ampoule, is usually only supplied overseas but has been approved under section 19A of the Therapeutic Goods Act 1989 for use during the shortage of DBL Ergometrine Injection (ergometrine maleate injection ampoule), AUST R58866.

Supply Interruption Notice for DBL ERGOMETRINE INJECTION 500MCG/1ML ampoule [AUST R 58866]
20 January

Pfizer advises of an upcoming interruption to supply of DBL ERGOMETRINE INJECTION 500MCG/1ML ampoule [AUST R 58866] due to a shortage in active pharmaceutical ingredients for DBL Ergometrine maleate injection ampoule. Pfizer is the sole supplier of this product in Australia. There are no safety concerns with the above product. Alternate suppliers, including LINK Healthcare may have potential therapeutic alternatives.

Medsurge S19A approval – Sertraline 50 mg and 100 mg tablets (S19A) (pack of 30)
12 January 

Medsurge advises that Sertraline 50 mg and 100 mg tablets, USP (Cipla) are now available as S19A until 30 June 2021, due to the shortage of APO-SERTRALINE sertraline (as hydrochloride) 50 mg tablet blister pack (ARTG 213177) and APO-SERTRALINE sertraline (as hydrochloride) 100 mg tablet blister pack (ARTG 213180).

Tenofovir Disoproxil Emtricitabine Mylan 300/200 tablets
8 January 

Link Medical Products Pty Ltd (LINK) advises that due to a shortage of Australian registered Tenofovir Disoproxil Emtricitabine Mylan 300/200 tablets (AUST R 265834) (which contains 300 mg of tenofovir disoproxil as maleate (equivalent to 245 mg of tenofovir disoproxil and 200 mg of emtricitabine)1, LINK has arranged supply of an alternative product, Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg Film-coated Tablets (TEVA UK Ltd) (which contains 245 mg of tenofovir disoproxil and 200 mg of emtricitabine) on a temporary basis. Please note: Tenofovir Disoproxil Emtricitabine Mylan 300/200 tablets (AUST R 265834) contains Tenofovir disoproxil as maleate salt, whereas Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg Film-coated Tablets (TEVA UK Ltd) contains tenofovir disoproxil as phosphate salt. Both products contain 245 mg Tenofovir disoproxil. Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg Film-coated Tablets (TEVA UK Ltd) are not registered in Australia and supply is granted under an approval granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 28 February 2021. Queries should be directed to medicine.shortages@linkhealthcare.com.au.

Neo‐Mercazole carbimazole 5mg tablet bottle
7 January 

Neo‐Mercazole carbimazole 5mg tablet bottle (ARTG 194296), sponsored by Amdipharm Mercury Australia Pty Ltd is in short supply due to manufacturing delays. Supply of Neo‐Mercazole carbimazole 5 mg tablet bottle is expected to resume 28 February 2021. Seed Pharma Pty Ltd has been able to arrange supply of an alternative product Carbimazole 5 mg tablets (DAWA Ltd) on a temporary basis. This product is NOT registered in Australia and supply is authorised under an approval granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act until 31 March 2021 for the following indication(s): Therapy of hyperthyroidism. Definitive therapy: induction of a permanent remission, in either primary or secondary thyrotoxicosis. Preparation for thyroidectomy. Before and after radioactive iodine treatment. Carbimazole 5 mg tablets (DAWA Ltd) is registered and marketed in the UK. Queries and orders should be directed to anz@seedpharma.com.

Recall action: ZERBAXA ceftolozane sulfate/tazobactam sodium 1000 mg/500 mg powder for injection
23 December

MSD, following consultation with the Therapeutic Goods Administration (TGA), is conducting a recall in Australia of ZERBAXA, batches S036990 and T025455. Due to a recent manufacturing issue identified during the routine testing of ZERBAXA (ceftolozane/tazobactam), manufacturing of the product has been temporarily stopped. The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. The investigation into the source of the R. Pickettii is ongoing and the seven batches have not been released to the market.

Shortage of Famotidine 20 mg and 40 mg tablets and alternative supply arrangement
18 December

Due to a shortage and discontinuation of multiple Australian registered Famotidine 20 mg and 40 mg tablets, LINK has arranged the temporary supply of alternative products. LINK can supply Famotidine 20 mg tablets (Tillomed) and Famotidine 40 mg tablets (Tillomed), registered and marketed in the United Kingdom. Famotidine 20 mg and 40 mg tablets (Tillomed) are not registered in Australia and supply is granted under an exemption by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 30 April 2022. Queries should be directed to medicine.shortages@linkhealthcare.com.au.

Shortage of DBL Pethidine Hydrochloride 50 mg/1 mL & 100 mg/2 mL injection BP ampoules and alternative supply arrangement
11 December

Due to a shortage of the Australian registered DBL Pethidine Hydrochloride 50 mg/1 mL and 100 mg/2 mL injection BP ampoule (AUST R 107386 and AUST R 107387), LINK has arranged the supply of an alternative product. LINK can supply Pethidine 50 mg/mL Solution for Injection ampoules (50 mg/mL & 100 mg/2 mL) registered and marketed in the United Kingdom. Pethidine 50 mg/mL solution for injection ampoules (50 mg/mL and 100 mg/2 mL) are NOT registered in Australia and supply is granted under an exemption granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act until 31 October 2021. Queries should be directed to medicine.shortages@linkhealthcare.com.au.

Shortage of famotidine 20 mg and 40 mg tablets and alternative supply arrangement
30 November

LINK has advised, that due to a shortage and discontinuation of multiple Australian-registered famotidine 20 mg and 40 mg tablets, they have arranged the temporary supply of alternative products. LINK can supply Famotidine 20 mg tablets (Tillomed) and Famotidine 40 mg tablets (Tillomed), registered and marketed in the United Kingdom. Famotidine 20 mg and 40 mg tablets (Tillomed) are not registered in Australia and supply is granted under an exemption by the Therapeutic Goods Administration under Section 19A of the Therapeutic Goods Act, 1989 until 31 January 2021.

Shortage of UREX FOTRE furosemide (Frusemide) 500mg tablet blister pack AUST R 196972
25 November

Medsurge has advised that Furosemid-Ratiopharm 500mg Furosemide Tablets is now available as S19A until 15 February 2021 due to the shortage of UREX FOTRE furosemide (Frusemide) 500 mg tablet blister pack AUST R 196972. Further information →

Shortage of fluoxetine 20 mg (as hydrochloride) capsule blister pack and alternate supply arrangement

9 November

Australian registered fluoxetine products, LOVAN fluoxetine 20 mg (as hydrochloride) capsule blister pack AUST R 54700 sponsored by Alphapharm Pty Ltd and PROZAC 20 fluoxetine 20 mg (as hydrochloride) capsule blister pack (ARTG 14653) sponsored by Eli Lilly Australia Pty Ltd are in shortage. Medsurge has been able to arrange for supply of Fluoxetine capsules USP 20 mg (ScieGen) 100 capsule bottle as an alternative product on a temporary basis. 

MS Contin® (modified-release morphine sulphate) suspension range discontinued
October

Mundipharma has advised that due to the scarcity of specific components, and no viable alternatives for continuing manufacture, production of the MS Contin® (modified-release morphine sulphate) suspension range (20mg, 30mg, 60mg, 100mg, 200mg) has ceased. Advice regarding alternative strong opioid analgesic medicines which may be suitable based on the prescriber’s clinical management is included in the notice.

Shortage of DBL Gentamicin 10 mg/1 mL (as sulfate) injection BP ampoule and alternative supply arrangement
22 October

LINK advises that due to a shortage of Australian registered DBL Gentamicin 10mg/1mL (as sulfate) injection BP ampoule (AUST R 16339), LINK has arranged the supply of an alternative product. LINK can supply Refobacin (gentamicin) 10 mg (10 mg/2 mL) ampoules, registered and marketed in Germany. Refobacin (gentamicin) 10mg (10mg/2mL) ampoules, is not registered in Australia and supply is granted under an exemption granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 31 March 2021.

Shortage of DIASP SR Dipyridamole/Aspirin 200 mg/25 mg modified release capsules bottle and ASASANTIN SR dipyridamole 200mg/aspirin 25mg sustained release capsule bottle and alternate supply arrangement
19 October

Medsurge has advised that Aspirin and ER Dipyridamole 25mg/200mg capsules (Pack of 60) is now available as S19A until 31 January 2021, due to the shortage of DIASP SR Dipyridamole/Aspirin 200mg/25mg modified release capsules bottle AUST R 210808. View prescribing information →

Shortage of Epirubicin Accord 200 mg/100 mL Aust R 227997 and alternative supply arrangement
26 August

Accord Healthcare Australia has advised of a shortage of Epirubicin Accord 200 mg/100 mL Aust R 227997 and alternative supply arrangement under Section 19A of the Therapeutic Goods Act 1989. The Australian registered medicine, Epirubicin Accord 200 mg/100 mL AUST R 227997, sponsored by Accord Healthcare Pty Ltd, is unavailable due to API supply issues. Supply of Epirubicin Accord 200 mg/100 mL is expected to resume March 2021. Accord Healthcare Pty Ltd has been able to arrange supply of an alternative product Epirubicin Accord 200 mg/100 mL (from Austria) on a temporary basis.

Interruption to supply for DIFLUCAN Fluconazole 50mg/5mL powder for oral suspension bottle
31 July

The supply interruption is due to manufacturing delay. There are no safety concerns with the above product. Pfizer is the sole supplier of this product in Australia. Alternate suppliers, including LINK Healthcare, may have potential therapeutic alternatives. LINK Healthcare can be contacted on telephone 1800 181 060 or email customerservice@linkhealthcare.com.au. Complete information regarding the approved indications for DIFLUCAN FLUCONAZOLE POWDER FOR ORAL SUSPENSION can be located in the Product Information available at www.tga.gov.au.

Shortage of TOFRANIL 25 imipramine hydrochloride 25mg tablet blister pack
10 July

The Australian registered medicine, TOFRANIL 25 imipramine hydrochloride 25mg tablet blister pack (AUST R: 60673), sponsored by Amdipharm Mercury Australia Pty Ltd, is currently in shortage due to manufacturing issues. Pro Pharmaceuticals Group has arranged for the supply of an alternative product, IMIPRAMINE HYDROCHLORIDE TABLETS USP, 25 MG 100 TABLETS (LEADING PHARMA LLC). This product is NOT registered in Australia and supply is authorised under an exemption granted by the Therapeutic Goods Administration (TGA) under section 19A of the Therapeutic Goods Act 1989 until 31st December 2020 for the following indications: major depression; nocturnal enuresis.

Shortage of auranofin (Ridaura®) Aust R 13000
29 June

The Australian registered medicine, auranofin (Ridaura®) Aust R 13000, sponsored by Amdipharm Mercury (Australia) Pty Ltd, has been discontinued. ADVANZ PHARMA has been able to arrange supply of an alternative product, Ridaura (Canada), on a temporary basis. ADVANZ PHARMA has been able to arrange supply of an alternative product, Ridaura (Canada), on a temporary basis. This product is NOT registered in Australia and supply is authorised under an approval granted by the Therapeutic Goods Administration (TGA) under section 19A of the Therapeutic Goods Act 1989 until 30 June 2021 for the following indication(s): “Adjunctive treatment of active classical or definite rheumatoid arthritis in adults who have an insufficient therapeutic response to, or are intolerant of, an adequate trial of a baseline therapeutic program, including among other measures, full doses of one or more nonsteroidal anti‐inflammatory drugs. Ridaura is not indicated in non‐rheumatoid arthropathies such as osteoarthrosis. Ridaura should be added to a comprehensive baseline therapeutic program.”

Discontinuation of Nardil (Phenelzine Sulfate)
22 June

Joint statement from the Therapeutic Goods Administration, the Royal Australian and New Zealand College of Psychiatrists, and the Society of Hospital Pharmacists of Australia: The sponsor of Nardil (phenelzine sulfate) tablets has notified the Therapeutic Goods Administration (TGA) that they can no longer supply this medication in Australia due to global issues with the manufacture of the active pharmaceutical ingredient. There are no alternative brands of phenelzine on the Australian market. Supplies of phenelzine tablets are very limited.

Interruption to supply of DBL™ Methotrexate 5mg/2mL vial
22 June

Pfizer has advised of an ongoing supply interruption of DBL™ Methotrexate 5mg/2mL vials due to a manufacturing delay. There are no safety concerns with the above product. Pfizer is the sole supplier of this presentation of methotrexate in Australia. Alternate suppliers, including LINK Healthcare and Medsurge, may have potential therapeutic alternatives.

Interruption to supply for DBL™ ERGOMETRINE INJECTION 500MCG/1ML AMPS

22 May

Pfizer has advised of an ongoing interruption to the supply of DBL™ ERGOMETRINE MALEATE INJECTION 500mcg/1mL amps ARTG: 58866 – pack size: 1 x 5mL vials, item code, back in stock date: late June 2020. M8008BAU. The supply interruption is due to a temperature deviation during transit. There are no safety concerns with the product. Alternate suppliers, including MEDSURGE, may have potential therapeutic alternatives. Complete information regarding the approved indications for DBL™ ERGOMETRINE MALEATE INJECTION can be located in the Product Information available on the TGA website.

Shortage of metformin modified-release 500 mg (multiple brands)

13 May

The Therapeutic Goods Administration (TGA) has been notified of current shortages for multiple brands of metformin modified-release 500 mg tablets (also known as extended-release or XR tablets). The shortages are expected to continue until 5 June 2020 at the earliest. Metformin is a prescription drug used to treat type 2 diabetes. In order to reduce the impact of this shortage on patients the TGA is issuing a Serious Shortage Medicine Substitution Notice for metformin modified-release 500mg. 

Discontinuation notice for DBL™ Heparin Sodium Injection BP (Sodium) 35,000 IU/35 ML vials [AUST R 16345]

29 April

After a thorough review, a decision has been made by Pfizer Australia to discontinue DBL™ Heparin Sodium Injection BP (Sodium) 35,000 IU/35 mL vials from the Australian market. The effective discontinuation date is 1st May 2020 and the product will be removed from PBS listing 1 July.

Discontinuation notice for Zavedos® (Idarubicin Hydrochloride) 5 MG capsules

29 April

After a thorough review, a decision has been made by Pfizer Australia to discontinue ZAVEDOS® (IDARUBICIN HYDROCHLORIDE) 5 MG CAPSULES from the Australian market. The effective discontinuation date is 1st May 2020 and the product will be removed from PBS listing 1 July.

Supply Interruption notice for DBL™ Gentamicin 10mg/1mL (as Sulfate) injection ampoule

29 April

Please be advised of an ongoing interruption to the supply of the following presentation listed below:

Presentation Pack size Pfizer item code Estimated out of stock date Back in stock date
DBL™ Gentamicin Injection 10mg/1mL AUST R 16339 5 x 1 mL ampoules M8380BAU1 Now Late Aug 2020

Shortage of Tazocin EF 4g/500mg powder for injection vial, AUST R 132525

17 April

Pfizer has advised the Australian registered medicine, TAZOCIN EF 4g/500mg powder for injection vial, AUST R 132525 sponsored by Pfizer Australia Pty Ltd is unavailable due to an unexpected manufacturing issue. Supply of TAZOCIN EF 4g/500mg powder for injection vial, AUST R 132525 is expected to resume in Jan 2021. Pfizer has been able to arrange supply of an alternative product, TAZOCIN EF 4g/500mg powder for injection vial [New Zealand] on a temporary basis.

Aminophylline injection supply interruption

6 April

Pfizer has advised of an ongoing interruption to the supply of DBL™ Aminophylline injection 250 mg in 10 mL due to a capacity issues at the manufacturing site and over demand of the product. Pfizer recognises this is a critical medicine and we are working with other suppliers to source an alternative product in place of the Australian registered product during this out of stock period and an update will be provided in May.

NARDIL phenelzine 15mg tablets discontinued

6 April

Link Medical Products has advised the manufacturing site for NARDIL phenelzine 15mg tablets has closed and they have been unable to secure adquate alternative options to cover the anticipated phenelzine requirements throughout 2020. 

Supply status of Celltrion Healthcare Biosimilar products in Australia

11 March

Celltrion Healthcare - Australia has provided an update of the supply status of Celltrion Healthcare Biosimilar products in Australia.

Neural connector changeover

30 August

The Australian and New Zealand College of Anaesthetists advises neural device connectors are changing to the ISO 80369-6 standard as part of an international patient safety measure to prevent the potentially fatal administration of medicines and substances.

Long-term interruption of DBL Morphine Tartrate 120mg/1.5mL injection ampoule

26 August

Pfizer has advised the supply interruption is due to an inability to source an alternate supplier for DBL MORPHINE TARTRATE 120mg/1.5mL INJECTION AMPOULE [AUST R 16324]. There are no safety concerns with the above product. Pfizer is the sole supplier of this product in Australia.

Shortage of Heparin Sodium 5000 IU/0.2 mL ampoule and alternative supply arrangement
16 August

Due to a shortage of the Australian registered DBL HEPARIN SODIUM 5000 IU/1 mL (porcine mucous) injection BP ampoule (AUST R 12881), LINK has arranged the supply of an alternative product. LINK can supply Heparin sodium 5000 IU/mL solution for injection or concentrate for solution for infusion (UK). This product is also from porcine intestinal mucosa origin. Heparin sodium 5000 IU/mL solution for injection or concentrate for solution for infusion (UK) is NOT registered in Australia and supply is granted under an exemption granted by the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act, 1989 until 10 October 2019.

Quarantine of Endone oxycodone hydrochloride 5mg tablet blister pack (batch CW612 only)
30 July

Aspen and the TGA are requesting hospital and retail pharmacies immediately quarantine all units of ENDONE oxycodone hydrochloride 5mg tablet blister pack from batch number CW612 only, until further notice, due to the potential for a rogue blister of Anamorph 30mg tablets. No stock is to be returned at this time. 

Medsurge updates
17 July

Medsurge have provided updates on the following medicines: AciVision 30mg/g, SINEMET CR 200mg/50mg slow release, DICLOXACILLIN, Azithromycin, Sulfamethoxazole and Trimethoprim, SINEMET tablet bottle, Fentanyl 100 microgram, STAPHYLEX and APO-FLUCLOXACILLIN and FERRO-LIQUID.

Marcain and Xylocaine Product Updates
31 May

Aspen Pharmacists has updated on the shortage of Marcain and Xylocain.

Shortage of Nardil
28 May

There is currently a shortage of Nardil 15mg tablets, Link medical products has arranged the supply of an alternate product

Shortage of Metoclopramide
28 May

There is currently a shortage of Metoclopramide Hydrochloride Monohidrate 10mg/2L injection ampuoles. Link medical products has arranged the supply of an alternate product. 

Shortage of SEPTRIN sugar-free oral liquid bottle
28 May 

There is currently a shortage of SEPTRIN sugar-free oral liquid, trimethoprim 40 mg/5 mL and sulfamethoxazole 200 mg/5 mL, 100 mL bottle (AUST R 11000). Link medical products has arranged the supply of an alternate product. 

Shortage of HEPARIN SODIUM 5000 IU/0.2 mL
24 May 

There is currently a shortage of Heparin Sodium 5000. Link medical products has arranged the supply of an alternate product. 

Shortage of Bleomycin sulphate powder for injection
6 May 

Cilpa Bleomycin have advised there is currently a shortage on Bleomycin sulphate powder for injection in Australia, there is an alternate product available as advised in the attached announcement. 

Shortage of Fentanyl Citrate injection ampoules
26 April 

There is currently a shortage of Fentanyl Citrate 100mcg/2 m: injection ampoules. LINK medical products are distributing Fentanyl Citrate Injection USP as a substitute as advised in the attached announcement.

Shortage of SPAN K Potassium Chloride 600mg
24 April 

There is currently a shortage of SPAN K potassium chloride 60mg Tablet bottle. LINK medical products are distributing EURO-K 600 tablets as a substitute as advised in the attached announcement.

Marcain®, Xylocaine and Naropin Shortage – updates on shortages

18 April 

Aspen Pharmacare advises there is a shortage of Marcain, Xylocaine and Naropin due to a fire at AstraZeneca's Swedish manufacturing site. AZ still cannot confirm the availability of other sterile theatre packed products listed in the attached announcement.

Shortage of Atrophine Sulphate pre-filled syringe
11 April 

There is currently a shortage of Atrophine Sulphate 1mg/5mL BP pre-filled syringe. LINK are supplying Atrophine Sulfate 1mg/5mL as a substitute as advised in the attached announcement. 

Shortage of ATROPINE INJECTION BP atropine sulfate monohydrate 600 microgram
4 April 

There is currently a shortage of ATROPINE INJECTION BP atropine sulfate monohydrate 600 microgram/1 mL injection BP ampoule, ATROPINE INJECTION BP atropine sulfate monohydrate 1.2 mg/1 mL injection BP ampoule and alternative supply arrangement under Section 19A of the Therapeutic Goods Act. An alternate product is available.

Shortage of azithromycin 500mg IV injection vial and supply of alternative medicine

21 March 

There is currently a shortage of Link azithromycin 500mg IV, alternate medicine ZEDBAC, azithromycin 500mg powder for solution vials as it has been granted an extension by the Therapeutic Goods of Australia.

Marcain®, Xylocaine and Naropin Shortage – updates on shortages
18 March 

Notification of Morphine Sulphate Injection BP in 1mL ampoules
15 March 

There is currently a shortage of Link Morphine Sulphate Injection BP in 1mL ampoules until June 30, 2019. Link medical products can supply an alternate product Morphine Sulfate Injection BP 30mg in 1mL ampoules. 

Shortage of DBL PETHIDINE HYDROCHLORIDE 50mg/1mL & 100mg/2mL injection BP ampoules and supply of alternative medicine

There is currently a shortage of Link medications  DBL PETHIDINE HYDROCHLORIDE 50mg/1mL and 100mg/2mL injection BP ampoules, alternate medicine, Pethidine 50 mg/mL Solution for Injection ampoules has been granted an extension by the Therapeutic Goods of Australia. 

Notification of some Marcain, Xylocaine and Naropin product shortage
4 March 

Due to a fire at AstraZeneca’s (AZ) Swedish manufacturing site, Aspen have provided an update regarding the availability of Naropin, Xylocaine and Marcain (Sterile Theatre Packed Polyamp) products, and Xylocaine with Adrenaline, Marcain with Adrenaline & other local anaesthetics.

Notification of Etopophos 100mg product shortage
6 February 

There is currently a stock shortage of Bristol Myers Squibb medication, Etopophos 100mg until late February.  However, Etopophos 1000mg (funded on the PBS) is still available without any supply restrictions.

Notification of some Marcain, Xylocaine and Naropin product shortage
31 January 

Due to a fire at AstraZeneca’s (AZ) Swedish manufacturing site, Aspen have provided an update regarding the availability of Naropin, Xylocaine and Marcain (Sterile Theatre Packed Polyamp) products, and Xylocaine with Adrenaline, Marcain with Adrenaline & other local anaesthetics.

ISUPREL isoprenaline hydrochloride 200 microgram/1mL injection ampoule
14 January 

Orpharma advises due to the shortage of the Australian registered ISUPREL isoprenaline hydrochloride 200 microgram/1mL injection ampoule, Orpharma has arranged the supply of an alternative product. Orpharma will supply ISOPRENALINE HYDROCHLORIDE MONICO 0.2mg/1mL solution for injection ampoule, registered and marketed in Italy.

ADRENALINE RENAUDIN, adrenaline 1mg/mL solution for injection ampoule

21 December 2018 

Due to the shortage of Australian registered ADRENALINE-LINK 1:1,000 1mg/mL adrenaline (epinephrine) acid tartrate injection BP ampoule (AUST R 10248) until mid-April 2019, LINK has arranged the supply of an alternative product. LINK can supply ADRENALINE RENAUDIN, adrenaline 1mg/mL solution for injection ampoule, registered and marketed in France.

Metformin Hydrochloride Slow Release 500mg and 1000mg tablets

20 December 2018

LINK has advised that due to a shortage of metformin hydrochloride 500mg and 1000mg extended release tablets, LINK has arranged the supply of an alternative product, Yaltormin SR 500mg Prolonged Release Tablets and Yaltormin SR 1000mg Prolonged Release.

Nefedipine 20mg modified release tablets

12 December 2018

Medsurge has advised that ADALAT OROS nifedipine 20mg tablet blister pack is in short supply due to manufacturing issues. Medsurge previously arranged to supply an alternative product Nifedipine AL T 20 Retard 20mg tablet blister pack, on a temporary basis however this approval has lapsed and Medsurge will cease the supply of this alternative product.

Nifedipine 10mg immediate release tablets

12 December 2018

Medsurge advises that ADALAT 10 nifedipine 10mg tablet blister pack has been discontinued and advises that medical professionals use the alternative ADEFIN 10 nifedipine 10mg tablet blister pack. 

Marcain®, Xylocaine and Naropin Shortage - updates on shortages

30 November 2018

Aspen Pharmacare advises there is a shortage of Marcain, Xylocaine and Naropin due to a fire at AstraZeneca's Swedish manufacturing site. AZ still cannot confirm the availability of other sterile theatre packed products listed in the attached announcement.

Tofranil imipramine hydrochloride 25mg tablets

2 October 2018

LINK has advised that due to a shortage of TOFRANIL, imipramine hydrochloride 25 mg tablets, AUST R 60673, LINK has arranged the supply of an alternative product Imipramin-neuraxpharm 25 mg.

Moxifloxican 400mg tablet blister pack

2 October 2018

LINK has advised that due to a shortage of AVELOX moxifloxacin 400 mg (as hydrochloride) tablet blister pack (AUST R 75766) and MOXIFLOXACIN APOTEX moxifloxacin (as hydrochloride monohydrate) 400 mg film coated tablet blister pack (AUST R 223564), LINK has arranged the supply of an alternative product Moxifloxacin (Actavis) 400 mg Film-coated Tablets registered and marketed in the United Kingdom.

SPAN K potassium chloride 600mg tablet bottle

20 September 2018

LINK has advied that due to a shortage of SPAN K potassium chloride 600mg tablet bottle, LINK has arranged the supply of an alternative product EURO-K 600 potassium chloride 600mg sustained release tablets USP. 

Suxamethonium Chloride Injection BP - updated temperative excursion data

19 September 2018

AstraZeneca advises that the accelerated stability data for Suxamethonium Chloride BP Polyamp DuoFit has been updated following completion of in-house stability tests for temperature excursions in August 2018. 

SEPTRIN sugar-free oral liquid bottle 
18 September 2018

LINK has advised that due to the shortage of SEPTRIN sugar-free oral liquid, trimethoprim 40mg/5ml and sulfamethoxazole 200mg/5ml, 100ml bottle, LINK has arranged for the supply of NOPIL fur Kinder Sirup, trimethoprim 40mg/5ml and sulfamethoxazole 200mg/5ml, 100ml bottle. 

MYAMBUTOL ethambutol hydrochloride 100mg tablet bottle discontinuation
6 September 2016

Orpharma advises that due to the discontinuation of the Australian registered MYAMBUTOL ethambutol hydrochloride 100mg tablet bottle, Orpharma has arranged the supply of ETHAMBUTOL (ethambutol hydrochloride) 100 mg tablet, registered in the UK. 

FENTANYL CITRATE 100 mcg/2 mL injection ampoule shortage
5 September 2018

LINK advises that due to a shortage of the Australian registered ASPEN FENTANYL fentanyl (as citrate) 100 mcg/2 mL solution for injection and 500 mcg/10 mL solution for injection, LINK has arranged for the alternative supply of Fentanyl 50 mcg/ml solution for injection (100 mcg/2 mL and 500/10 mL).

DBL ERGOMETRINE INJECTION 500 mcg/mL ampoule shortage
31 August 2018

LINK advises that due to a shortage of the Australian registered DBL ERGOMETRINE INECTION, ergometrine maleate (500 mcg/mL) ampoule, LINK has arranged the alternative supply of ERGONOVINE MALEATE INJECTION (ergonovine maleate injection, USP) 0.25 mg/mL, ampoules registered and marketing in Canada. 

ISUPREL isoprenaline hydrochloride 200 micrograms/1mL injection ampoule shortage - update

27 August 2018

Orpharma advises that due to the shortage of Australian registered ISUPREL isoprenaline hydrochloride 200 microgram/1mL injection ampoule, the supply of an alternative product has been arranged. Orpharma will supply ISOPRENALINE HYDROCHLORIDE MONICO 0.2mg/1mL solution for injection ampoule, registered and marketed in Italy.  

Lomustine (CEENU) 100mg cessation of supply
7 August 2018

Bristol-Myers Squibb Australia advises that the 100mg ampoules of Lomustine(CEENU) will be no longer available in Australia from November 2018. The 10mg and 40mg ampoules will continue to be available. This change has occurred due to cessation of global manufacturing of the 100mg ampoule.

HEPARIN SODIUM 5000 IU/5 mL ampoule shortage
12 July 2018

LINK advises that due to a shortage of the Australian registered DBL HEPARIN SODIUM (porcine mucous) 5000IU/5mL injection ampoule (AUST R 49232), LINK has arranged the supply of Heparin sodium 1,000 I.U./mL solution for injection or concentrate for solution for infusion, 5mL ampoules (5,000 I.U./5mL) registered and marketed in the United Kingdom. 

TOFRANIL, imipramine hydrochloride 25mg tablets
1 July 2018

TOFRANIL, imipramine hydrochloride 25 mg tablets, AUST R 60673, LINK has arranged the supply of an alternative product currently registered in Germany.  This product is Imipramin-neuraxpharm 25 mg and supply is authorised under an exemption grated by the TGA under section 19A of the Therapeutic Goods Act (1989) until 30 September 2018.

HEPARINISED SALINE 50IU/5ml ampoule

19 June 2018

LINK advises that due to a shortage of the Australian registered HEPARINISED SALINE 50IU/5mL (porcine mucous) 50IU/5mL injection ampoule (AUST R 66684). INK can supply Heparin Sodium 10 I.U./mL flushing solution for maintenance of patency of intravenous devices (50 I.U. in 5mL) registered and marketed in the United Kingdom.

AZACTAM (aztreonam) 1g Powder for injection shortage

11 May 2018

Bristol Myers Squibb Australia advises that due to a manufacturing issue at the active substance manufacturing plance there is a shortage of AZACTAM (aztreonam) 1g powder for injection. Current stock is likely to be depleted by 25 May 2018 with partial re-supply by mid-June. BMS recommends all health care providers prioritise aztreonam for patients they feel are in the greatest need with no other alternative.

HEPARIN SODIUM 5000 IU/0.2 mL ampoule shortage
20 April 2018

LINK advises that due to a shortage of the Australian registered DBL HEPARIN SODIUM (porcine mucous) 5000IU/0.2mL injection BP ampoule (AUST R 16349), LINK has arranged the supply of HeparinNatrium-5000-ratiopharm, heparin sodium 5000 IU/0.2 mL ampoules registered and marketed in Germany and supply is granted under an exemption granted by the Therapeutic Goods Administration under Section 19A of the Therapeutic Goods Act, 1989 until 15 October 2018. 

Phenobarbitone tablets 30mg 200 delay

17 April 2018

Arrow Pharmaceutical advises that due to manufacturing capacity constrains, deliver of Phenobarb tablets 30mg 200 is not expected until early June 2018. 

DANTRIUM® powder for injection 20mg vials

8 February 2018

Pfizer advises there is a shortage in Dantrium® powder for injection 20mg vials and supply of an alternative product Dantrium® Intravenous 20mg powder for solution for injection (Norgine) has been arranged on a temporary basis. 

Chlorhexidine injection risks

January 2018

The Australian and New Zealand College of Anaesthetists and the Australian Commission on Safety and Quality in Health Care have developed a safety statement in response to reported incidents of accidental injection of chlorhexidine, a surface disinfectant.  

DBL™ Metronidazole Intravenous Infusion 500mg in 100mL bag

8 January 2018

Pfizer advises that batch 70094/March 2019 of DBL™ Metronidazole Intravenous Infusion 500 mg in 100 mL infusion bags are being recalled based on a customer report that a single unit from a 10 unit box had visible black particles reported as mould between the infusion bag and plastic overwrap.

Methylprednisolone acetate Suspension for Injection 40mg per mL

12 December 2017 

Pfizer advises there is an interruption to supply for DEPO-NISOLONE™ Injection 40mg per mL and there will be an interruption to the supply of DEPO-MEDROL™ Injection 40mg per mL from late January 2018, due to unexpected manufacturing delay. 

DBL™ Diazepam Injection 10mg/2ml ampoules

28 November 2017

Pfizer advises there is an interruption in supply for DBL™ Diazepam Injection 10 mg/2ml ampoules, due to an unexpected manufacturing delay. Judicious use of ampoules is recommended during the current constraints on supply and use should be reserved where no therapeutic alternatives are available.

Hydroxyurea

22 November 2017

Bristol Myers-Squibb advises there is a global shortage of supply of HYDREA hydroxycarbamide (hydroxyurea) and that stocks will be depleted by early December 2017. It is expected that supply will be re-instated by 15 January 2018. 

Methotrexate Injection BP 50mg/2 mL vial shortage

15 November 2017

Pfizer advises there is an interruption in supply for Methotrexate Plastic Cytosafe Vial 50 mg/2mL (Pfizer) and DBL™ Methotrexate Injection BP  50 mg/2 mL vial, due to an unexpected manufacturing delay. 

Pamisol 15mg/5mL vial and 90mg/10mL injection vial shortage

15 November 2017

Pfizer advises there is an interruption in supply for Pamisol (disodium pamidronate) 15mg/5mL and 90mg/10mL injection vials, due to unexpected manufacturing delay. 

Methotrexate Injection BP 50mg/2 mL vial shortage

26 October 2017

Pfizer advises there is an interruption in supply for Methotrexate Plastic Cytosafe Vial  50 mg/2mL (Pfizer) and DBL™ Methotrexate Injection BP  50 mg/2 mL vial, due to an unexpected manufacturing delay.  

Cytarabine Injection 2g in 20 mL vial and Vincristine Sulfate Injection 2mg in 2mL vial shortage
23 October 2017

Pfizer advises there is an interruption in supply for Cytarabine Injection 2g in 20 mL vial and Vincristine Sulfate Injection 2mg in 2mL vial, due to an unexpected manufacturing delay. 

Gentamicin Injection BP 80 mg in 2 mL Steriluer® - Product recall
6 October 2017

Pfizer advises that, following an internal investigation, ten batches of Gentamicin Injection BP 80 mg in 2 mL Steriluer® are being recalled as they may contain a higher than expected intrinsic constituent (histamine) in the finished product. View recall notice.

Dexamethasone sodium phosphate shortage
1 May 2017

TGA updated medicine shortage information.

Phenoxybenzamine hydrochloride shortage
1 May 2017

TGA updated medicine shortage information.

DANTRIUM (dantrolene sodium) Powder for Injection 20 mg- Updates on shortage
7 April 2017

Pfizer advises there is an interruption in supply for Dantrium (dantrolene sodium) powder for injection 20mg, due to an unexpected manufacturing delay.
Previous notice.

EpiPen 300 microgram adrenaline injection syringe auto-injector
20 March 2017

The TGA has issued recall for four batches of the EpiPen 300 microgram adrenaline injection syringe auto-injector. EpiPens from affected batches can be returned to pharmacies for a refund or exchanged for one from a different, unaffected batch free of charge.

Etopophos (etoposide phosphate) powder for injection vials and Vepesid etoposide capsules
14 February 2017

The TGA have announced that there are current shortages of Etopophos etoposide 1 g (as phosphate) and Etopophos etoposide phosphate 113.6 mg (equivalent to 100 mg etoposide) powder for injection vials and Vepesid etoposide 50 mg capsule blister packs. The Vepesid etoposide 100 mg capsule blister pack shortage has been resolved.

Glyceryl trinitrate tablets (Anginine and Lycinate) potential medicine shortage and alternative product
9 February 2017

The TGA have announced that following the potential shortage of glyceryl trinitrate tablets due to reformulation, an alternative supply (Nitrostat tablets) has now been approved. Please note that the TGA anticipate a shortage for the alternative product 600 mcg (0.6 mg) of Nitrostat tablets.

Metformin tablet shortage — Updates on availability
19 January 2017

The TGA has released a statement advising consumers and health professionals about a change in status in the availability of metformin extended release tablets.

Stonefish Antivenom 2000U Injection Vial
10 January 2017

Seqirus advises that Stonefish AV Lot 056007501 has 2.52 mL product volume, instead of the volume of 2.29 mL. 

Urgent recall for Dilantin

5 December 2016

Pfizer issued a recall of dilantin (phenytoin sodium) 30 mg capsule bottle, 100 mg capsule bottle and dilantin (phenytoin) infatabs 50 mg tablet bottle.  

Discontinuation of Modecate (fluphenazine decanoate) injection
1 December 2016

Bristol Myers Squibb advise that they will cease supply of Modecate (fluphenazine decanoate) injection and expect supply to be depleted between March and August 2017. The information is also available via the TGA website.

Supply information regarding Etopophos inj (etoposide phosphate),Vumon inj (teniposide) and Vepesid (etoposide) 
25 November 2016

Bristol Myers Squibb have released updates in the supply of three medicines. Etopophos inj (etoposide phosphate) remains out of stock. Vumon inj (teniposide) is to cease supply due to the end of global production and Vepesid (etoposide) 50mg capsules are in short supply, with the next shipment expected to arrive mid-December 2016. Update: Vepesid (etoposide) 50mg capsules are still in short supply.

Aciclovir 250 mg/10 mL injection anticipated shortage
11 November 2016

Medicine shortage information about aciclovir injection has been posted on the TGA website.

Carbimazole Manufacturing Delays
6 October 2016

Link Healthcare has issued a notification to address the shortage of Australian registered carbimazole 5mg tablets. Link has been granted TGA approval to supply German registered Carbimzol Aristo 5mg tablets.

Angiomax (bivalirudin) updated safety information
1 October 2016

The Medicines Company issued a letter to inform of updates in important new safety information regarding contraindications, precautions, dosage and administration of angiomax (bivalirudin).

Recall for GlucaGen HypoKit
12 September 2016

The TGA has released a statement regarding their decision to recall four batches of the GlucaGen HypoKit. It has been identified that a small number of GlucaGen HypoKits have needles which may become detached from the pre-filled syringes. Patients who return affected products will be given free replacements.

Recall for APO-Cabergoline
2 September 2016

The TGA has released a statement regarding Apotex and their decision to recall one batch of APO-Cabergoline 500mcg tablets due to a packaging issue, which could potentially lead to the product degrading over time in moist conditions.   

Safety alert for Actilyse (alteplase)
22 August 2016

Boehringer Ingelheim has issued a safety alert regarding an issue during reconstitution of Actilyse (alteplase (rch)) 50 mg powder for injection. Boehringer Ingelheim emphasises the importance of strict compliance with handling instructions provided on the packaging of the transfer cannula.

Monoplus and Monopril discontinuation
22 August 2016

Bristol-Myers Squibb has issued a letter regarding the decision to discontinue Monoplus 10mg (fosinopril 10mg and hydrochlorothiazide 12.5mg), Monoplus 20mg (fosinopril 20mg and hydrochlorothiazide 12.5mg) and Monopril 20mg (fosinopril 20mg) tablets in Australia.