Revised: 30 November 2015
Committees
Summary of Recommendations from the 102nd meeting of the Medicines Assessment Advisory Committee held in the Rydges Wellington, 75 Featherston Street, Pipitea, Wellington 6011 on Tuesday 29 September 2015 at 9:30 am
Present:
Associate Professor Richard Robson (Chair)
Associate Professor Christopher Frampton
Professor Paul Glue (via teleconference)
Dr Debora Greig
Dr Rupert Handy
Dr AbiGail Rayner
Mrs Catherine Ryan
Dr Paul Tomlinson
Dr David Woolner
Ms Hannah Hoang (Secretary)
In Attendance (from Medsafe):
Mrs Frances Barton (Team Leader, Medicines Assessment)
Dr Adrian Britt (Senior Advisor, Medicines Assessment)
Ms Alyssa Currie (Team Leader, Committee and Support Services, Product Regulation)
Ms Sarah Reader (Manager, Product Regulation)
Mrs Leah Russell (Team Leader, Medicines Assessment)
In Attendance (for specific agenda items only):
Dr Kuntal (SUN Pharma Ltd)
Apologies:
Associate Professor Paul Fawcett
Dr Mark Jeffery
Dr Daniel Wright
5 |
Applications for consent to distribute a new medicine under section 20 of the Medicines Act 1981 (referred by the Minister of Health under section 22(2)) |
5.2 |
Liposomal Doxorubicin SUN 2 mg/mL concentrate for infusion Pharmacy Retailing (NZ) Ltd t/a Healthcare LogisticsThat the Minister of Health should defer making a decision to grant consent to the distribution of the medicine Liposomal Doxorubicin SUN 2 mg/mL concentrate for infusion under section 20 of the Medicines Act 1981. The recommendation was due to further studies being carried out and the results should be evaluated by Medsafe; this information includes the results from a new bioequivalent study using 50 mg/m2 dosage, ongoing tissue distribution studies and dose linearity information that the company presented at this meeting. |
