Articles

The Product Information for ocrelizumab has been updated to include a warning and further information about late onset neutropenia.

The TGA has provisionally approved the use of the Pfizer BNT162b2 COVID-19 vaccine (COMIRNATY) in individuals 12 years and older.

PI used by healthcare professionals updated

The TGA has issued an infringement notice for $2,664 to an individual from Canberra, for a breach of the Therapeutic Goods Act 1989 in relation to the alleged unlawful advertising of a homoeopathic medicine with COVID-19 claims.

Information about the TGA's safety monitoring of COVID-19 vaccines.

Health professionals are advised that the Product Information (PI) documents for methylphenidate products have been updated with new information about use in pregnancy.

Information about the TGA's safety monitoring of COVID-19 vaccines.

This instrument is made under subregulations 4A.2(4) of the Therapeutic Goods (Medical Devices) Regulations 2002.

Information about the TGA's safety monitoring of COVID-19 vaccines.

Joint ICMRA/WHO Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness.

Information for health professionals

The TGA has issued seven infringement notices totalling $93,240 to Melbourne-based global biopharmaceutical company Starpharma Holdings Limited (Starpharma), for alleged illegal advertising of a nasal spray that is not approved for use in Australia.

Information about the TGA's safety monitoring of COVID-19 vaccines.

The TGA granted provisional approval to Janssen-Cilag Pty Ltd (known as Johnson & Johnson overseas) for its COVID-19 vaccine Janssen, making it the third COVID-19 vaccine to receive regulatory approval in Australia.

Information about the TGA's safety monitoring of COVID-19 vaccines.

The TGA, part of the Department of Health, has granted provisional determination to Moderna Australia Pty Ltd in relation to the COVID-19 Vaccine, Elasomeran

Health professionals are advised that the Product Information (PI) documents for combined oral contraceptives containing dienogest have been updated to include more detailed information on the risk of venous thromboembolism.

Health professionals are advised that the Product Information (PI) documents for sertraline have been updated to include microscopic colitis as a potential adverse effect of unknown frequency based on post-marketing experience.

The recommended duration of contraception after finishing tamoxifen treatment has been extended from two months to nine months.

Information about the TGA's safety monitoring of COVID-19 vaccines.

Interaction between TGA and AHPRA advertising guidelines

Consumer goods with button batteries

Information about the TGA's safety monitoring of COVID-19 vaccines.

The TGA has issued two infringement notices totalling $26,640 to Sydney company Aidacare Pty Ltd (Aidacare).

The TGA is seriously concerned about misleading information that has been broadcast on radio stations providing a distorted picture of the safety of COVID-19 vaccines.