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: Advil Childrens 2-7 Years Chewable
Active Ingredient: Ibuprofen 100mg
Dosage Form: Chewable tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Canada Inc., Montreal, Canada
Product: Advil Childrens 7-12 Years Chewable (Pharmacy Only)
Active Ingredient: Ibuprofen 100mg
Dosage Form: Chewable tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Canada Inc., Montreal, Canada
Product: Advil Childrens 7-12 Years Chewable (General Sale)
Active Ingredient: Ibuprofen 100mg
Dosage Form: Chewable tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Canada Inc., Montreal, Canada
Product: Alfentanil 500 micrograms/ml
Active Ingredient: Alfentanil hydrochloride 0.5438mg/mL equivalent to Alfentanil 0.5 mg/ml
Dosage Form: Solution for injection
New Zealand Sponsor: Max Health Limited
Manufacturer: Hameln Pharmaceuticals GmbH, Hameln, Germany
Product: Paracide
Active Ingredient: Permethrin 5%w/w
Dosage Form: Lotion
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Hoe Pharmaceuticals Sdn Bhd, Selangor, Malaysia
Product: Topiramate Actavis 25
Active Ingredient: Topiramate 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Actavis hf., Hafnarfjordur, Iceland
Product: Topiramate Actavis 50
Active Ingredient: Topiramate 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Actavis hf., Hafnarfjordur, Iceland
Product: Topiramate Actavis 100
Active Ingredient: Topiramate 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Actavis hf., Hafnarfjordur, Iceland
Product: Topiramate Actavis 200
Active Ingredient: Topiramate 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Actavis hf., Hafnarfjordur, Iceland
Dated this 28th day of March 2014.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).