Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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: Antifungal Clotrimazole Cream
Active Ingredient: Clotrimazole 10mg/g
Dosage Form: Topical cream
New Zealand Sponsor: PSM Healthcare Limited trading as API Consumer Brands
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
   
Product: Ibuprofen
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: PSM Healthcare Limited trading as API Consumer Brands
Manufacturer: Medreich Limited, Bangalore, India
   
Product: Kanjinti
Active Ingredient: Trastuzumab 60mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Amgen New Zealand Limited
Manufacturer: Actavis Italy S.p.A, Nerviano, Italy
   
Product: Kanjinti
Active Ingredient: Trastuzumab 150mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Amgen New Zealand Limited
Manufacturer: Actavis Italy S.p.A, Nerviano, Italy
   
Product: Kanjinti
Active Ingredient: Trastuzumab 440mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Amgen New Zealand Limited
Manufacturer: Actavis Italy S.p.A, Nerviano, Italy
   
Product: Zovirax Duo
Active Ingredients: Aciclovir 5%w/w
Hydrocortisone 1%w/w
Dosage Form: Topical cream
New Zealand Sponsor: GlaxoSmithKline Consumer Healthcare New Zealand ULC
Manufacturer: Glaxo Operations UK Limited t/a Glaxo Welcome Operations, Barnard Castle, United Kingdom


Dated this 29th day of January 2021.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).