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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Codral Multi Action Cold & Flu
Active Ingredients: Chlorphenamine maleate 2mg
Codeine phosphate hemihydrate 9.5mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Probiotec Pharma Pty Limited, Melbourne, Australia
Product: Protamine Sulphate
Active Ingredient: Protamine sulfate 1%
Dosage Form: Solution for injection
New Zealand Sponsor: Artex Limited
Manufacturers: Agila Specialties Polska Sp. z o.o, Warsaw, Poland
CP Pharmaceuticals Limited, Wrexham, United Kingdom
Product: Voltaren Emulgel
Active Ingredient: Diclofenac diethylamine 1.16% equivalent to Diclofenac 1%
Dosage Form: Topical gel
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturers: Novartis Consumer Health SA, Nyon, Switzerland
Novartis Pharma Produktions GmbH, Wehr, Germany
Product: Voltaren Osteo
Active Ingredient: Diclofenac diethylamine 1.16% equivalent to Diclofenac 1%
Dosage Form: Topical gel
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturers: Novartis Consumer Health SA, Nyon, Switzerland
Novartis Pharma Produktions GmbH, Wehr, Germany
Dated this 16th day of December 2013.
SARAH READER, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).