Section A: Premarket registration applications
At this meeting, the committee provided advice on 3 applications under evaluation by the TGA, as below.
| Active ingredient (TRADENAME) | Sponsor | Therapeutic area | Application designations |
|---|---|---|---|
| Applications for a 'new indication', or additional therapeutic use, for an already approved vaccine (Application Type C) | |||
mifepristone, misoprostol (MS-2 STEP Composite Pack) | MS Health Pty Ltd | Termination of pregnancy and miscarriage | |
drospirenone (LYNDELLE) | Besins Healthcare Australia Pty Ltd | Contraception and pelvic pain in endometriosis | |
onasemnogene abeparvovec (ITVISMA) | Novartis Pharmaceuticals Australia Pty Ltd | Spinal muscular atrophy (SMA) | |
oxymetazoline hydrochloride (MAYNE OXYMETAZOLINE) | Mayne Pharma International Pty Ltd | Persistent facial erythema associated with rosacea | |
tirzepatide (MOUNJARO) | Eli Lilly Australia Pty Ltd | Type 2 diabetes mellitus | |
The dates of commencement of the evaluation of these applications are available at Prescription medicines: applications under evaluation, see: Prescription medicines: Applications under evaluation.
The committee also provided advice on:
- one application for major variations (new dosage form, change/increase in patient group, change in dosage, new strength, new route of administration) (Application Type F)
- 1 nomination for the Medicines Repurposing Program.
Further details of the ACM discussion and advice associated with these items may be released within the Australian Public Assessment Reports (AusPARs). To browse all AusPARs see: Australian Public Assessment Reports (AusPAR).
Section B: Post-market items
The ACM was not asked to provide advice on a post-market or safety issue.
Further information
For further information on the Advisory Committee on Medicines, please visit: Advisory Committee on Medicines (ACM) or contact the ACM Secretary by email: ACM@health.gov.au.