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: Curash BabyCare Medicated Nappy Rash Cream
Active Ingredient: Zinc oxide 200mg/g
Dosage Form: Topical cream
New Zealand Sponsor: Pharmabroker Sales Limited
Manufacturer: Ensign Laboratories Pty Limited, Mulgrave, Australia
Product: Ibuprofen
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Ipca Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli, India
Product: Itch-Soothe
Active Ingredient: Crotamiton 10%w/w
Dosage Form: Topical cream
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Hoe Pharmaceuticals Sdn Bhd, Bandar Sultan Suleiman, Pelabuhan Klang, Selangor, Malaysia
Product: Zapril
Active Ingredient: Cilazapril, anhydrous 5mg equivalent to Cilazapril monohydrate 5.22mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Pharmaceuticals ULC, Etobicoke, Ontario, Canada
Product: Zapril
Active Ingredient: Cilazapril, anhydrous 2.5mg equivalent to Cilazapril monohydrate 2.61mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Pharmaceuticals ULC, Etobicoke, Ontario, Canada
Dated this 13th day of November 2009.
MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).