We are aware of an issue causing the title of some ARTG entries to disappear. We are investigating as a priority and hope to have this resolved as soon as possible.
Section A: Pre-market registration applications referred for advice
At this meeting, the committee’s advice was sought on 2 applications under evaluation by the TGA. The applications included:
| Active ingredient (TRADENAME) | Sponsor | Therapeutic area |
|---|---|---|
| Type C (extension of indications) | ||
| remdesivir (VEKLURY) | Gilead Sciences Pty Ltd | For treatment of COVID-19 |
*These application types are published on Prescription medicines: applications under evaluation.
In addition to:
- One seeking a major variation (change in dosage)
Further details of the ACM discussion and advice associated with these items may be released within the Australian Public Assessment Reports (AusPARs). Please note that there is a delay from when an application was considered at ACM and the publication of the AusPAR. Browse all AusPARs.
Further information
For further information visit the Advisory Committee on Medicines or contact the ACM Secretary by email: ACM@health.gov.au.