TGA

TGA
Share

TGA

 •  April 5

Investigation of adverse event ('side effect') reports is an important way that the Therapeutic Goods Administration (TGA) monitors the safety of medicines and vaccines used in Australia. We are undertaking a survey to seek information about your experiences and attitudes towards key issues related to medicines and their use. Your responses will...

TGA

 •  February 9

In response to the recent article from Pharma in Focus, the Therapeutic Goods Administration (TGA) provides the following clarification. The TGA operates on a fully cost-recovery basis. It is important to maintain fees and charges current and reflecting the larger number of applications received each year and their complexity. The TGA engaged...

TGA

 •  January 12

Sponsors of therapeutic goods needing to initiate a product recall are reminded that the new URPTG takes effect on Monday, 15 January 2018. For further details, refer to Uniform recall procedure for therapeutic goods (URPTG), V2.0, October 2017 or contact the TGA Recalls Unit on 02 6232 8935 or by email recalls@health.gov.au (link sends...

TGA

 •  October 24, 2017

Following two cycles of public consultation on the regulation of autologous human cell and tissue products in 2015 and 2016, the Government has decided that changes to regulation should be implemented. As a result of the changes, some of these products will be subject to regulation as biologicals by the TGA, with the level of regulation being...

TGA

 •  October 6, 2017

Consumers and health professionals are advised that Pfizer Australia, in consultation with the TGA, is recalling 10 batches of Gentamicin Injection BP 80 mg in 2 mL Steriluer ampoules in packs of 10 and 50. Gentamicin Injection belongs to a group of medicines known as aminoglycoside antibiotics, which work by preventing bacteria from growing and...

TGA

 •  September 12, 2017

Consumers and health professionals are advised that LivaNova, in consultation with the TGA, has issued a hazard alert regarding certain models of Platinium Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds). LivaNova is also recalling unused stock of these devices. ICDs are implantable...

TGA

 •  August 11, 2017

Consumers and health professionals are advised that Pfizer, in consultation with the TGA, is undertaking a recall for product correction of one batch (Batch A473, expiry date Feb 2019) of Heparin 5000 IU/5 mL injection 50 pack ampoules because of the potential for the packaging to contain another product. Users with potentially affected products...

TGA

 •  August 11, 2017

Consumers and health professionals are advised that Pfizer, in consultation with the TGA, is undertaking a recall for product correction of one batch (Batch A313, expiry date Nov 2017) of Lignocaine 50 mg/5 mL ampoules because of the potential for the packaging to contain another product. Users with potentially affected products are asked to...

TGA

 •  August 11, 2017

Consumers and health professionals are advised that Pfizer, in consultation with the TGA, is undertaking recalls for product correction involving Heparin 5000 U/5 mL injection 50 pack (Batch A473, expiry date Feb 2019) and Lignocaine 50 mg/5 mL ampoules (Batch A313, expiry date Nov 2017) due to the potential for incorrect products in packages....

TGA

 •  July 19, 2017

Pharmaceutical company Novo Nordisk A/S, in consultation with the TGA, has initiated a consumer level recall of some batches of their NovoPen Echo insulin cartridge holder after detecting there is a possibility they may crack or break if exposed to chemicals in certain cleaning agents. People using a device with a cracked or broken cartridge...