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ACM meeting statement, Meeting 15, 7 June 2019
Advisory Committee on Medicines
Overview of therapeutic goods referred for advice
At this meeting, the committee’s advice was sought on 9 applications under evaluation by the TGA. The applications included:
- one for the registration of a new chemical entity
- five seeking extensions of indications
- one seeking registration of a new dose
- one seeking safety-related changes to the Product Information.
The ACM also provided additional advice on the registration of a new chemical entity which had first been considered at an earlier ACM meeting.
Further details of the ACM discussion and advice associated with these items are 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. To browse all AusPARs see: AusPAR search
Overview of the safety reviews referred for advice
The TGA continually monitors therapeutic goods supplied in Australia to ensure their ongoing safety, efficacy and quality. As part of this process, the TGA routinely undertakes safety reviews of therapeutic goods. No review was referred to the ACM at this meeting.