Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Glycopyrronium Bromide 200 micrograms per ml Solution for Injection
Active Ingredient: Glycopyrronium bromide 0.2mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Max Health Limited
Manufacturer: Macarthys Laboratories Limited t/a Martindale Pharmaceuticals, Essex, United Kingdom
Product: Paroxetine Sandoz
Active Ingredient: Paroxetine hydrochloride 22.2mg equivalent to paroxetine 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Salutas Pharma GmbH, Barleben, Germany
Dated this 6th day of June 2013.
DR MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).