Regulatory revelations


jar with capsules

New PBS listings from special meeting revealed, while the TGA warns on a new product shortage  

A special meeting of the Pharmaceutical Benefits Advisory Committee (PBAC) in December 2016 has led to a series of new PBS listings and changes, according to newly released documents.

The PBAC special meeting, held in December, saw decisions reached on six product listings.

Among the recommendations is a new listing of naloxone in the form of naloxone hydrochloride 1 mg/ mL injection, 1 x 2 mL pre-filled syringe for at-home use and use by laypeople.

The PBAC recommended that this new listing should be consistent with that for the currently listed naloxone product with the exception that naloxone hydrochloride 1 mg/mL injection, 1 x 2 mL pre-filled syringe not be made available as a prescriber bag item.

Other new listings include adding pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) under certain conditions on a cost-minimisation basis to nintedanib and listing of chloramphenicol 0.5% eye drops, 10 mL as a restricted benefit for Aboriginal and Torres Strait Islander patients.

Adalimumab, Everolimus and glyceryl trinitrate are the other products mentioned in the December meeting reports.

Click here for the full listing of the meeting outcomes

Meanwhile, the TGA has issued a warning advising there is now limited availability of the hyperthyroidism treatment Neo-Mercazole (carbimazole) 5 mg, marketed in Australia by Amdipharm Mercury.

Carbimazole is used in the treatment of hyperthyroidism.

The current shortage is due to a delay in the manufacturing schedule, the TGA advises and the sponsor is working closely with manufacturers to expedite delivery of stock.

An alternative supply has been arranged, with the TGA approval of a section 19A application for the import and supply of a UK product, Carbimazole tablets 5 mg.

If Neo-Mercazole is unavailable, pharmacies can obtain Carbimazole tablets 5 mg (UK) by contacting Amdipharm Mercury (Australia) by phone on 1800 235 305 or email

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