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 - Amitriptyline
Active Ingredient: Amitriptyline hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Arrow - Amitriptyline
Active Ingredient: Amitriptyline hydrochloride 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Arrow - Amitriptyline
Active Ingredient: Amitriptyline hydrochloride 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Botox®
Active Ingredient: Botulinum A toxin 200U
Dosage Form: Powder for injection
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan Pharmaceuticals Ireland, County Mayo, Ireland
Product: Codral Relief Max Strength 6 Signs Cold & Flu
Active Ingredients: Guaifenesin 200mg
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: IPCA - Amitriptyline
Active Ingredient: Amitriptyline hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: IPCA - Amitriptyline
Active Ingredient: Amitriptyline hydrochloride 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: IPCA - Amitriptyline
Active Ingredient: Amitriptyline hydrochloride 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: PAC - Amitriptyline
Active Ingredient: Amitriptyline hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: PAC - Amitriptyline
Active Ingredient: Amitriptyline hydrochloride 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: PAC - Amitriptyline
Active Ingredient: Amitriptyline hydrochloride 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Primovist
Active Ingredient: Gadoxetate disodium 181.43mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Pharma AG, Berlin, Germany
Product: Your Pharmacy Cough, Cold + Flu PE Hot Drink
Active Ingredients: Guaifenesin 200mg
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 Day + Night Cold & Flu Relief PE
Day Tablet
Active Ingredients: Codeine phosphate 6mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
Night Tablet
Active Ingredients: Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
Product: Your Pharmacy Night Time Cold & Flu Relief PE
Active Ingredients: Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
Product: Your Pharmacy Sinus with Antihistamine PE
Active Ingredients: Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
Dated this 23rd day of February 2012.
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).