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: Anapen
Active Ingredient: Adrenaline 1mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Link Pharmaceuticals Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Anapen Junior
Active Ingredient: Adrenaline 500µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Link Pharmaceuticals Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Apo-Clomipramine
Active Ingredient: Clomipramine hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Aspirin
Active Ingredient: Aspirin 300mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Manufacturing Division, Taluka - Daund, District - Pune, Maharashtra State, India
Product: Irinotecan Actavis 100
Active Ingredient: Irinotecan hydrochloride 100mg
Dosage Form: Concentrate for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: SC Sindan-Pharma SrL, Bucharest, Romania
Product: Irinotecan Actavis 40
Active Ingredient: Irinotecan hydrochloride 40mg
Dosage Form: Concentrate for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: SC Sindan-Pharma SrL, Bucharest, Romania
Product: Laxofast 120
Active Ingredient: Docusate sodium 120mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Softgel Healthcare Pvt. Limited, Kancheepuram District, Tamilnadu, India
Product: Laxofast 50
Active Ingredient: Docusate sodium 50mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Softgel Healthcare Pvt. Limited, Kancheepuram District, Tamilnadu, India
Product: Lemsip Max All in One Cold & Flu
Active Ingredients: Guaifenesin 200mg
Paracetamol 1000mg
Phenylephrine hydrochloride 12.2mg equivalent to 10mg phenylephrine
Dosage Form: Powder for oral solution
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Hull, North Humberside, United Kingdom
Product: Lemsip Max Cold & Flu with Decongestant Hot Drink
Active Ingredients: Paracetamol 1000mg
Phenylephrine hydrochloride 12.2mg equivalent to 10mg phenylephrine
Dosage Form: Powder for oral solution
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Hull, North Humberside, United Kingdom
Product: Nu-Lax Block
Active Ingredient: Senna leaf 80mg/g
Dosage Form: Block
New Zealand Sponsor: Medconsult Services Limited
Manufacturer: Orchard Manufacturing Co Pty Limited, Bayswater, Australia
Product: Nu-Lax Bar
Active Ingredients: Ficus carica 306mg/g
Phoenix dactylifera 306mg/g
Senna leaf 80mg/g
Dosage Form: Block
New Zealand Sponsor: Medconsult Services Limited
Manufacturer: Orchard Manufacturing Co Pty Limited, Bayswater, Australia
Dated this 25th day of November 2009.
STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).