Articles

Product Information documents for parenteral iron products are currently being updated to include information about fetal bradycardia and Kounis syndrome.

The Product Information for nifedipine has been updated to provide new information about the risk of acute pulmonary oedema when used as a tocolytic agent (inhibiting myometrial smooth muscle contractions) for the treatment of preterm labor in pregnancy.

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.

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

Information for health professionals

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.

Consumer goods with button batteries

We are improving the Medicine Shortages IT System.

Remaking of standards and legislative instruments for human cell and tissue (HCT) products, blood and blood components

Updated storage conditions for the Pfizer COVID-19 vaccine

The TGA granted a provisional determination to GlaxoSmithKline Australia Pty Ltd in relation to the monoclonal antibody treatment, SOTROVIMAB (GSK4182136) on 14 April 2021

The granting of this determination means that Pfizer is now eligible to apply to vary its provisional registration for the vaccine for use in individuals 12 years of age or older.

The TGA is warning consumers about the risks of buying medicinal cannabis products online

The TGA is reminding businesses involved with medicinal cannabis products of their regulatory obligations under the Therapeutic Goods Act 1989

Medicines Safety Update article

The TGA have made some changes to the SAS & AP Authorised Prescriber Online System.

The granting of a provisional determination means that the TGA has made a decision that GSK is now eligible to apply for provisional registration for the treatment in the Australian Register of Therapeutic Goods.

Updated storage conditions for the Pfizer COVID-19 vaccine

The Scheduling Delegate has decided to seek further advice in relation to psilocybin and MDMA

Sunscreen SPF testing by AMA Laboratories - Regulatory update. Possible fraudulent testing of sunscreens and TGA efforts to mitigate effect on Australian consumers.