Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Ava 20
Active Ingredients: Ethinylestradiol 0.02mg
Levonorgestrel 0.1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Famy Care Limited, Gujarat, India
Product: Ava 20 ED
Active Ingredients: Ethinylestradiol 0.02mg
Levonorgestrel 0.1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Famy Care Limited, Gujarat, India
Product: Codral Relief 6 Signs Cold & Flu
Active Ingredients: Guaifenesin 100mg
Paracetamol 500mg
Phenylephrine hydrochloride 6.1mg equivalent to phenelphrine 5mg
Dosage Form: Capsule
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Perrigo UK Limited, Devon, United Kingdom
Product: DBL™ Meropenem for Injection
Active Ingredient: Meropenem trihydrate 570.475mg equivalent to meropenem 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Healthcare India Pvt. Limited, Tamil Nadu, India
Product: DBL™ Meropenem for Injection
Active Ingredient: Meropenem trihydrate 1140.95mg equivalent to meropenem 1000mg
Dosage Form: Powder for injection
New Zealand Sponsor: Hospira NZ Limited
Manufacturer: Hospira Healthcare India Pvt. Limited, Tamil Nadu, India
Product: Latisse
Active Ingredient: Bimatoprost 0.3mg/mL
Dosage Form: Topical solution
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan Sales LLC, Texas, United States of America
Product: Lax-Sachets
Active Ingredients: Macrogol 3350 13.125g
Potassium chloride 46.6mg
Sodium bicarbonate 178.5mg
Sodium chloride 350.7mg
Dosage Form: Powder for oral solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Strides Arcolab Limited, Bangalore, India
Product: Lax-Sachets Half
Active Ingredients: Macrogol 3350 6.563g
Potassium chloride 23.3mg
Sodium bicarbonate 89.25mg
Sodium chloride 175.35mg
Dosage Form: Powder for oral solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Strides Arcolab Limited, Bangalore, India
Product: Lo-Oralcon 20
Active Ingredients: Ethinylestradiol 0.02mg
Levonorgestrel 0.1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Famy Care Limited, Gujarat, India
Product: Lo-Oralcon 20 ED
Active Ingredients: Ethinylestradiol 0.02mg
Levonorgestrel 0.1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Famy Care Limited, Gujarat, India
Product: Nicorette® QuickMist Mouth Spray
Active Ingredient: Nicotine tartrate 13.6mg/mL
Dosage Form: Oral spray
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: McNeil AB, Helsingborg, Sweden
Product: Oseltamivir
Active Ingredient: Oseltamivir phosphate 98.5mg
Dosage Form: Capsule
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India
Product: Your Pharmacy Cough, Cold & Flu PE
Active Ingredients: Guaifenesin 100mg
Paracetamol 500mg
Phenylephrine hydrochloride 6.1mg equivalent to phenelphrine 5mg
Dosage Form: Capsule
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Wrafton Laboratories Limited, Devon, United Kingdom
Dated this 7th day of December 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).