ARTG
Zantac set for front-of-shop return
TGA gives green light for Zantac’s reinstatement on the ARTG Aspen Pharmacare Australia’s Zantac (ranitidine (as hydrochloride)) products are set to return to pharmacy and grocery stores’ shelves following its …
Profession needs vape guidelines
TGA urged to review vapes and produce guidelines to allay pharmacists’ concerns about stocking products The Therapeutic Goods Administration (TGA) needs to review the safety, efficacy and performance of vaping …
Unapproved hay fever product could contain botox
The TGA says it’s aware that a product called “Haytox” is being promoted as a treatment for nasal allergies – but it’s not TGA-approved or on the ARTG “The TGA …
TGA fines health practitioners over S4 imports
Regulator issues infringement notices to health practitioners for alleged unlawful importation of unregistered prescription medicines The Therapeutic Goods Administration (TGA) has issued fines totaling $13,320 to three separate health professionals …
Pharmacist directly imported hormone and ED treatments
A formerly registered pharmacist has been reprimanded after he bypassed the Australian Therapeutic Goods Regulatory Framework to import drugs not registered on the ARTG The Pharmacy Board has issued a …
Symbicort now registered for mild asthma
New indication means budesonide/formoterol can be prescribed as needed (PRN) for patients with mild asthma, without daily maintenance treatment Symbicort Turbuhaler 200/6 and Symbicort Rapihaler 100/3 can now be prescribed …
An Australian first
Pembrolizumab (Keytruda) is the first medicine to have additional indications registered on the ARTG via the TGA’s provisional approval pathway “Pembrolizumab’s indications now include the treatment of patients with metastatic …
Medicine reforms ‘good news’: ASMI CEO
Recent medicine reforms, in particular those for complementary medicines, make manufacturers more accountable for product claims, writes Deon Schoombie Complementary medicines are regulated as medicines under the Therapeutic Goods Act …