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: Brilinta
Active Ingredient: Ticagrelor 90mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, S"dertälje, Sweden
Product: Codral Relief Max Strength Cold & Flu + Decongestant
Active Ingredients: Paracetamol 1000mg
Phenylephrine hydrochloride 12.2mg
Dosage Form: Powder
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Wrafton Laboratories Limited, Devon, United Kingdom
Product: Duro-Tuss Phenylephrine PE Chesty Cough & Nasal Decongestant
Active Ingredients: Bromhexine hydrochloride 0.08%w/v
Phenylephrine hydrochloride 0.067%w/v
Dosage Form: Oral solution
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: iNova Pharmaceuticals (Australia) Pty Limited, Thornleigh, Australia
Product: Onbrez Breezhaler
Active Ingredient: Indacaterol maleate 0.194mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacture: Novartis Pharma Stein AG, Stein, Switzerland
Product: Onbrez Breezhaler
Active Ingredient: Indacaterol maleate 0.389mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Your Pharmacy Cold & Flu Hot Drink PE
Active Ingredients: Paracetamol 1000mg
Phenylephrine hydrochloride 12.2mg
Dosage Form: Powder
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Wrafton Laboratories Limited, Devon, United Kingdom
Product: Your Pharmacy Paediatric Paracetamol Suspension
Active Ingredient: Paracetamol 2%w/w
Dosage Form: Oral solution
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
Dated this 10th day of August 2011.
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).