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: A-Fluconazole
Active Ingredient: Fluconazole 50mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: A-Fluconazole
Active Ingredient: Fluconazole 150mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: A-Fluconazole
Active Ingredient: Fluconazole 200mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Codral Cold & Flu Sore Throat (General Sale)
Active Ingredients: Ibuprofen 200mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Johnson & Johnson Pty Limited, Cape Town, South Africa
Product: Codral Cold & Flu Sore Throat (Pharmacy Only)
Active Ingredients: Ibuprofen 200mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Johnson & Johnson Pty Limited, Cape Town, South Africa
Product: Fluconazole
Active Ingredient: Fluconazole 50mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Fluconazole
Active Ingredient: Fluconazole 150mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Fluconazole
Active Ingredient: Fluconazole 200mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Ibuprofen
Active Ingredient: Ibuprofen 200mg
Dosage Form: Coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Marksans Pharma Limited, Goa, India
Product: I-Fluconazole
Active Ingredient: Fluconazole 50mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: I-Fluconazole
Active Ingredient: Fluconazole 150mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: I-Fluconazole
Active Ingredient: Fluconazole 200mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India
Product: Imodium Advanced
Active Ingredients: Loperamide hydrochloride 2mg
Simeticone 125mg
Dosage Form: Chewable tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Johnson & Johnson / Merck Consumer Pharmaceutical Company, Pennsylvania, United States of America
Product: Imodium Caplets
Active Ingredient: Loperamide hydrochloride 2mg
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico
Product: Nuromol (General Sale)
Active Ingredients: Ibuprofen 200mg
Paracetamol 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, United Kingdom
Product: Nuromol (Pharmacy Only)
Active Ingredients: Ibuprofen 200mg
Paracetamol 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, United Kingdom
Product: Sudafed PE Sinus + Anti-inflammatory Pain Relief (General Sale)
Active Ingredients: Ibuprofen 200mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Johnson & Johnson Pty Limited, Cape Town, South Africa
Product: Sudafed PE Sinus + Anti-inflammatory Pain Relief (Pharmacy Only)
Active Ingredients: Ibuprofen 200mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Johnson & Johnson Pty Limited, Cape Town, South Africa
Product: Vagifem Low
Active Ingredients: Estradiol hemihydrate 0.0103mg equivalent to anhydrous estradiol 10mcg
Dosage Form: Pessary
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, M†løv, Denmark
Product: Voltaren Spray
Active Ingredient: Diclofenac sodium 4%w/w
Dosage Form: Topical spray
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturer: Pharbil Waltrop GmbH, Waltrop, Germany
Dated this 17th day of June 2011.
MARK JACOBS, Acting 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).