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: Arrow - Lattim
Active Ingredients: Latanoprost 0.05mg/mL
Timolol maleate 6.8mg/mL equivalent to Timolol 5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: FDC Limited, District Aurangabad, India
Product: Cavstat
Active Ingredient: Rosuvastatin calcium 5.198mg equivalent to Rosuvastatin 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Cavstat
Active Ingredient: Rosuvastatin calcium 10.396mg equivalent to Rosuvastatin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Cavstat
Active Ingredient: Rosuvastatin calcium 20.792mg equivalent to Rosuvastatin 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Cavstat
Active Ingredient: Rosuvastatin calcium 41.584mg equivalent to Rosuvastatin 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Mylan Rosuvastatin
Active Ingredient: Rosuvastatin calcium 5.198mg equivalent to Rosuvastatin 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Mylan Rosuvastatin
Active Ingredient: Rosuvastatin calcium 10.396mg equivalent to Rosuvastatin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Mylan Rosuvastatin
Active Ingredient: Rosuvastatin calcium 20.792mg equivalent to Rosuvastatin 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Mylan Rosuvastatin
Active Ingredient: Rosuvastatin calcium 41.584mg equivalent to Rosuvastatin 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Valaciclovir RBX
Active Ingredient: Valaciclovir hydrochloride 556.275mg equivalent to Valaciclovir 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Himachal Pradesh, India
Dated this 25th day of September 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).