September 2018

Important New Products

• Apalutamide (Erlyand) is an androgen receptor (AR) inhibitor that binds directly to the ligand ...(more)
• Rufinamide (Inovelon) is a carboxamide derivative antiepileptic that modulates the activity of ...(more)

New Indications

• Dabrafenib (Tafinlar) in combination with trametinib is now indicated for the adjuvant treatment ...(more)
• Denosumab (rch) (Xgeva) is now indicated for prevention of skeletal related events associated ...(more)
• Nivolumab (Opdivo) in combination with ipilimumab is now indicated for the treatment of: ...(more)
• Osimertinib (mesilate) (Tagrisso) is now indicated for first-line treatment of locally advanced or ...(more)
• Terlipressin (Lucassin) is now indicated for treatment of bleeding oesophageal varices.

New Contraindications

• Enoxaparin sodium (Clexane and Clexane Forte) is now contraindicated with immune ...(more)
• Erythromycin (Eryc Capsules, Mayne Pharma Erythromycin) is now contraindicated with ...(more)

Active Ingredient Naming Changes

In this release, MIMS Australia will be including the following INNs (International Non-proprietary Names) as well as Australian Approved Names (AANs) as part of our push to support the Therapeutic Goods Administration (TGA) active ingredient name changes project.  

MIMS will begin referring to these ingredients by their new names, however, users may continue to search by the old AANs if preferred. ...(more)

Black triangle scheme

Black triangle medicinal products are subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems. ...(more)

Black triangle scheme to promote adverse event reporting

The Therapeutic Goods Administration (TGA) is implementing a black triangle scheme.

Commencing January 2018, the scheme is designed to help health professionals and patients to identify certain types of new prescription medicines, and to encourage the reporting of adverse events associated with their use. A similar scheme currently operates throughout the member states of the European Union, including the United Kingdom. ...(more)