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: Avonex Pen
Active Ingredient: Interferon beta-1a 60µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers: Catalent Pharma Solutions LLC, Pennsylvania, United States of America
Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Biogen Idec Denmark Manufacturing ApS, Hillerod, Denmark
Product: Lemsip Ibuprofen Cold & Flu Liquid Capsules
Active Ingredients: Ibuprofen 200mg
Phenylephrine hydrochloride 5mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Softgel Healthcare Pvt. Limited, Tamilnadu, India
Product: Lemsip Multi Relief Cold & Flu Liquid
Active Ingredients: Guaifenesin 200mg
Paracetamol 1000mg
Phenylephrine hydrochloride 12.2mg
Dosage Form: Linctus
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Yorkshire, United Kingdom
Product: Nurofen Cold & Flu PE Liquid Capsules
Active Ingredients: Ibuprofen 200mg
Phenylephrine hydrochloride 5mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Softgel Healthcare Pvt. Limited, Tamilnadu, India
Product: Paracetamol-AFT
Active Ingredient: Paracetamol 10mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturers: Fresenius Kabi Deutschland GmbH, Friedberg, Germany
S.M. Farmaceutici SRL, Zona Industriale, Italy
Dated this 5th day of July 2012.
DR STEWART JESSAMINE, 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).