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))

5.1

Bortezomib – Dr Reddy’s, 3.5 mg, powder for injection (TT50-9579)
Dr Reddy’s New Zealand Limited

Secretary’s note – The recommendation has not been published because Dr Reddy’s New Zealand Limited withdrew this application on 13 April 2017, following notification of the recommendation.

5.2

Lidocaine, 1%, and 2%, solution for injection (TT50-9609, a)
B. Braun New Zealand Limited

That the Minister of Health should refuse consent to the distribution of the medicine Lidocaine as a generic application under section 20 of the Medicines Act 1981.
 
The recommendation was a result of the fact that the requested course of regulatory evaluation was not suitable for Lidocaine (B. Braun), which had resulted in a number of outstanding issues and concerns.