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ACM meeting statement, Meeting 12, 6 December 2018

Advisory Committee on Medicines

ACM 12 meeting statement has been published

Published

Section A: Submissions for registration

The advice of the Advisory Committee on Medicines (ACM) was sought on eleven new pre-market applications for prescription medicines, as tabulated below.

Number of applications consideredApplication TypeMain consideration by ACM
5Type A - New chemical /biological entityFor general consideration
1Type B - New combination of active ingredientsFor general consideration
1Type B - New combination of active ingredients and Type A - New chemical entityFor general consideration
3Type C - Extension of indicationFor consideration of broader indication with or without substantiating supportive evidence.
1Type C - Extension of indication and Type F - Major variation (strength)For general consideration

Further details of the ACM discussions and advice associated with pre-market items are released within the Australian Public Assessment Reports (AusPARs) for each new active. Please note that there is a delay from when an application was considered at ACM, and the publication of the AusPAR. Browse all AusPARs.

Section B: Post-Market items referred for advice

No post-market items were referred for advice.

Further information

For further information on the ACM, please visit Advisory Committee on Medicines or contact the ACM Secretary by email: ACM@health.gov.au.

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