Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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 - Ropinirole 0.25
Active Ingredient: Ropinirole hydrochloride 0.285mg equivalent to 0.25mg ropinirole
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Australia
Product: Arrow - Ropinirole 0.5
Active Ingredient: Ropinirole hydrochloride 0.57mg equivalent to 0.5mg ropinirole
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Australia
Product: Arrow - Ropinirole 1
Active Ingredient: Ropinirole hydrochloride 1.14mg equivalent to 1mg ropinirole
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Australia
Product: Arrow - Ropinirole 2
Active Ingredient: Ropinirole hydrochloride 2.28mg equivalent to 2mg ropinirole
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Australia
Product: m-Pergolide
Active Ingredient: Pergolide mesilate 0.0655mg equivalent to 0.05mg pergolide
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Pharmathen SA, Attikis, Greece
Product: m-Pergolide
Active Ingredient: Pergolide mesilate 0.3275mg equivalent to 0.25mg pergolide
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Pharmathen SA, Attikis, Greece
Product: m-Pergolide
Active Ingredient: Pergolide mesilate 1.31mg equivalent to 1mg pergolide
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Pharmathen SA, Attikis, Greece
Product: Next Choice
Active Ingredient: Levonorgestrel 0.75mg
Dosage Form: Tablet
New Zealand Sponsor: Spirit Pharmaceuticals NZ Limited
Manufacturer: Watson Laboratories Inc, Corona, United States of America
Product: Nurofen for Children Baby 3+ months (concentrated, strawberry)
Active Ingredient: Ibuprofen 40mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Hull, United Kingdom
Product: Nurofen for Children Baby 3+ months (concentrated, orange)
Active Ingredient: Ibuprofen 40mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Hull, United Kingdom
Product: Nurofen for Children Infant Drops
Active Ingredient: Ibuprofen 40mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Farmasierra Manufacturing SL, Madrid, Spain
Product: Paclitaxel Actavis
Active Ingredient: Paclitaxel 30mg
Dosage Form: Concentrate for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: SC Sindan-Pharma SrL, Bucharest, Romania
Product: Paclitaxel Actavis
Active Ingredient: Paclitaxel 100mg
Dosage Form: Concentrate for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: SC Sindan-Pharma SrL, Bucharest, Romania
Product: Paclitaxel Actavis
Active Ingredient: Paclitaxel 150mg
Dosage Form: Concentrate for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: SC Sindan-Pharma SrL, Bucharest, Romania
Product: Paclitaxel Actavis
Active Ingredient: Paclitaxel 300mg
Dosage Form: Concentrate for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: SC Sindan-Pharma SrL, Bucharest, Romania
Product: Pradaxa
Active Ingredient: Dabigatran etexilate 172.95mg equivalent to 150mg free base
Dosage Form: Capsule
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
Product: Rivastigmine
Active Ingredient: Rivastigmine tartrate 2.4mg
Dosage Form: Capsule
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Rivastigmine
Active Ingredient: Rivastigmine tartrate 4.8mg
Dosage Form: Capsule
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Rivastigmine
Active Ingredient: Rivastigmine tartrate 7.2mg
Dosage Form: Capsule
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Rivastigmine
Active Ingredient: Rivastigmine tartrate 9.6mg
Dosage Form: Capsule
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: SMOFlipid.
Active Ingredients: Fish oil 30g
Medium-chain triglycerides 60g
Olive oil 50g
Soya oil 60g
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturer: Fresenius Kabi AB, Uppsala, Sweden
Dated this 20th day of December 2010.
JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).