TGA
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 …
Fluoridated water not the TGA’s remit
The TGA has issued a clarification saying that state and territory governments will continue to be responsible for regulating fluoride in tap water “Legislative amendments made on 11 July 2019 …
Don’t keep strong pain medicines ‘just in case’
TGA rolls out campaign to curb opioid harm Community pharmacies across Australia will receive 500 repeat script covers encouraging safe disposal of unwanted medicines, as the TGA rolls out its …
Change is coming
Get ready for the big ingredient name changes in 2020, regulator warns The TGA is advising health professionals and consumers alike to be ready for the 2020 deadline for the …
The top ten
What were the ten most clicked stories on the AJP website over the last month? Regulatory and legal issues, Chemist Warehouse, scheduling changes and flu vaccines head up the list …
Advice on ‘natural’ claims
The TGA has released “substantially revised” guidance on the use of the word “natural” and related claims when advertising medicines and medical devices to the public The organisation notes that …
Staying the same
Mometasone to remain a mostly prescription product after downscheduling application is knocked back TGA regulators have rejected a proposal to move the corticosteroid mometasone to become a Schedule 3 product. …
Popping out
Pharmacies to dispense product used as a sex aid following TGA ruling The Therapeutic Goods Administrations’ scheduling committee has recommended some of a range of products currently used as sex …
Paracetamol on the move
Modified release paracetamol upscheduled to S3, but GP groups express concern about the move Modified release paracetamol are set to be re-scheduled as S3 (Pharmacist Only) products according to the …
Safety advisories: how Australia compares
Research shows communication about emerging safety risks of medicines is not consistent between countries… and the Australian regulator issued fewer warnings than other countries A new study has analysed how …
Codeine drop ‘not necessarily a marker for success’
A new TGA report says the upschedule meant a “significant” drop in the amount of codeine supplied to Australians – but a Guild spokesperson says it’s early days yet A …
Keeping your hair on
Leading hair-loss treatment could be set to move to pharmacist-only category Regulators are set to decide on a request to down-schedule a leading hair-loss treatment to the S3 (Pharmacist Only) …