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: Apo-Pantoprazole
Active Ingredient: Pantoprazole sodium sesquihydrate 22.6mg equivalent to 20mg pantoprazole
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Apo-Pantoprazole
Active Ingredient: Pantoprazole sodium sesquihydrate 45.2mg equivalent to 40mg pantoprazole
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Fluoxetine
Active Ingredient: Fluoxetine hydrochloride 22.5mg equivalent to 20mg fluoxetine
Dosage Form: Capsule
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Micro Labs Limited, Tamil Nadur, India
Product: Myloc CR
Active Ingredient: Metoprolol succinate 190mg equivalent to 77.69mg free drug base
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Acino Pharma AG, Liesberg, Switzerland
Product: Myloc CR
Active Ingredient: Metoprolol succinate 47.5mg equivalent to 19.42mg free drug base
Dosage Form: Modified release tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Acino Pharma AG, Liesberg, Switzerland
Product: Myloc CR
Active Ingredient: Metoprolol succinate 95mg equivalent to 38.84mg free drug base
Dosage Form: Modified release tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Acino Pharma AG, Liesberg, Switzerland
Product: Myloc CR
Active Ingredient: Metoprolol succinate 23.75mg equivalent to 9.71mg free drug base
Dosage Form: Modified release tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Acino Pharma AG, Liesberg, Switzerland
Product: Panadol Cold & Flu Night Relief PE
Active Ingredients: Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Australia Pty Limited, Ermington, Australia
Product: Vaclovir
Active Ingredient: Valaciclovir hydrochloride 307.295mg equivalent to 250mg valaciclovir
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India
Product: Vaclovir
Active Ingredient: Valaciclovir hydrochloride 614.59mg equivalent to 500mg valaciclovir
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturers: Matrix Laboratories Limited, Nashik, India
Product: Vaclovir
Active Ingredient: Valaciclovir hydrochloride 1229.18mg equivalent to 1000mg valaciclovir
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturers: Matrix Laboratories Limited, Nashik, India
Product: Votrient
Active Ingredient: Pazopanib hydrochloride 216.7mg equivalent to 200mg pazopanib base
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Hertfordshire, United Kingdom
Product: Votrient
Active Ingredient: Pazopanib hydrochloride 433.4mg equivalent to 400mg pazopanib base
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Hertfordshire, United Kingdom
Product: Zomig Nasal Spray
Active Ingredient: Zolmitriptan 5mg
Dosage Form: Nasal spray solution
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca UK Limited, Macclesfield, United Kingdom
Dated this 9th day of September 2010.
JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).