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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: Apo-Gabapentin
Active Ingredient: Gabapentin 300mg
Dosage Form: Capsule
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Etobicoke, Ontario, Canada
Product: Apo-Gabapentin
Active Ingredient: Gabapentin 400mg
Dosage Form: Capsule
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Etobicoke, Ontario, Canada
Product: Lemsip Max Cold & Flu + Chesty Cough
Active Ingredients: Guaifenesin 200mg
Paracetamol 1,000mg
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: Nicotinell (Mint Flavoured)
Active Ingredient: Nicotine 2mg
Dosage Form: Lozenge
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited
Manufacturers: Sanico NV, Turnhout, Belgium
SwissCo Services AG, Sisseln, Switzerland
Product: SimStatin
Active Ingredient: Simvastatin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturers: Rottendorf Pharma GmbH, Ennigerloh, Germany
Synthon Hispania SL, Poligno Las Salinas, Sant Boi de Llobregat, Barcelona, Spain
Product: SimStatin
Active Ingredient: Simvastatin 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturers: Rottendorf Pharma GmbH, Ennigerloh, Germany
Synthon Hispania SL, Poligno Las Salinas, Sant Boi de Llobregat, Barcelona, Spain
Product: SimStatin
Active Ingredient: Simvastatin 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturers: Rottendorf Pharma GmbH, Ennigerloh, Germany
Synthon Hispania SL, Poligno Las Salinas, Sant Boi de Llobregat, Barcelona, Spain
Product: SimStatin
Active Ingredient: Simvastatin 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturers: Rottendorf Pharma GmbH, Ennigerloh, Germany
Synthon Hispania SL, Poligno Las Salinas, Sant Boi de Llobregat, Barcelona, Spain
Product: Sodium Chloride 0.9%
Active Ingredient: Sodium chloride 9mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Demo SA, Kryoneri, Athens, Greece
Dated this 12th day of January 2007.
BARRY BORMAN, Acting-Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).