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Section A: Premarket registration applications
At this meeting the committee provided advice on one application under evaluation by the TGA.
| Active ingredient (TRADENAME) | Sponsor | Therapeutic area | Application designations |
|---|---|---|---|
| Application for a 'new vaccine' containing a new active substance (new chemical entity or new biological entity) not currently approved in Australia (Application Type A) | |||
pneumococcal purified capsular polysaccharides (Tradename to be confirmed) | Merck Sharp & Dohme (Australia) Pty Ltd
| Active immunisation for the prevention of pneumococcal disease in adults | |
The date of commencement of the evaluation of the application is available at Prescription medicines: Applications under evaluation.
Further details of the ACV discussion and advice associated with items may be released within the Australian Public Assessment Reports (AusPAR).
Section B: Post-market items
The ACV was not asked to provide advice on a post-market or safety issue.
Further information
For further information on the Advisory Committee on Vaccines, please visit: Advisory Committee on Vaccines (ACV) or contact the ACV Secretary by email: ACV@health.gov.au.