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: Colgate Sensitive Pro-Relief - Peppermint
Active Ingredients: Arginine 8%w/w
Sodium monofluorophosphate 1.1%w/w
Dosage Form: Toothpaste
New Zealand Sponsor: Colgate-Palmolive Limited (NZ)
Manufacturer: Colgate-Palmolive Ind£stria e Com‚rcio LTDA, S'o Paulo, Brazil
Product: DBLT Gemcitabine Injection
Active Ingredient: Gemcitabine hydrochloride 43.3mg/mL equivalent to gemcitabine 38mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturers: Hospira Australia Pty Limited, Mulgrave, Australia
Zydus Hospira Oncology Limited (ZHOPL), Gujarat, India
Product: Paracetamol (Ethics Cherry Flavour)
Active Ingredient: Paracetamol 24mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Meditab Specialities Pvt Limited, Maharashtra, India
Product: Paracetamol (Ethics Strawberry Flavour)
Active Ingredient: Paracetamol 24mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Meditab Specialities Pvt Limited, Maharashtra, India
Dated this 15th day of August 2013.
DR DON MACKIE, 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).