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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

Product: Clexane Syringe
Active Ingredient: Enoxaparin sodium 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Sanofi-Aventis New Zealand Limited
Manufacturers: Sanofi Winthrop Industrie, Maisons-Alfort, France
Sanofi Aventis SA, Madrid, Spain
   
Product: Clexane Ampoule
Active Ingredient: Enoxaparin sodium 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Sanofi-Aventis New Zealand Limited
Manufacturers: Sanofi Winthrop Industrie, Le Trait, France
Sanofi Winthrop Industrie, Maisons-Alfort, France
   
Product: Clexane Forte
Active Ingredient: Enoxaparin sodium 150mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Sanofi-Aventis New Zealand Limited
Manufacturers: Sanofi Winthrop Industrie, Le Trait, France
Sanofi Winthrop Industrie, Maisons-Alfort, France
   
Product: Demazin Cold Relief Blue
Active Ingredients: Chlorphenamine maleate 0.25mg/mL
Phenylephrine hydrochloride 0.5mg/mL
Dosage Form: Syrup
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Aspen Pharma Pty Limited, Melbourne, Australia
   
Product: Demazin Cold Relief Colour Free
Active Ingredients: Chlorphenamine maleate 0.25mg/mL
Phenylephrine hydrochloride 0.5mg/mL
Dosage Form: Syrup
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturer: Aspen Pharma Pty Limited, Melbourne, Australia
   
Product: Dysport
Active Ingredient: Clostridium botulinum type A toxin haemagglutinin complex 300U
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Ipsen Biopharm Limited, Wrexham, United Kingdom
   
Product: Dysport
Active Ingredient: Clostridium botulinum type A toxin haemagglutinin complex 500U
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Ipsen Biopharm Limited, Wrexham, United Kingdom
   
Product: Kuvan
Active Ingredient: Sapropterin dihydrochloride 100mg equivalent to sapropterin 77mg
Dosage Form: Soluble tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Excella GmbH & Co KG, Feucht, Germany
   
Product: Minims Prednisolone Sodium Phosphate
Active Ingredient: Prednisolone sodium phosphate 0.5%w/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: Bausch & Lomb (NZ) Limited
Manufacturer: Laboratoire Chauvin SA, Aubenas, France
   
Product: Zinnat
Active Ingredient: Cefuroxime axetil 300.72mg equivalent to cefuroxime 250mg
Dosage Form: Film coated tablet
New Zealand Sponsor: GlaxoSmithKline NZ Limited
Manufacturer: Glaxo Operations UK Limited t/a Glaxo Welcome Operations, County Durham, United Kingdom
   
Product: Zoloft
Active Ingredient: Sertraline hydrochloride 56mg equivalent to sertraline 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Upjohn New Zealand ULC
Manufacturers: Pfizer Italia SrL, Latina, Italy
Pfizer Pharmaceuticals Limited, Dalian, China
Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany
   
Product: Zoloft
Active Ingredient: Sertraline hydrochloride 111.9mg equivalent to sertraline 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Upjohn New Zealand ULC
Manufacturers: Pfizer Australia Pty Limited, Sydney, Australia
Pfizer Italia SrL, Latina, Italy
Pfizer Pharmaceuticals Limited, Dalian, China
Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany


Dated this 12th day of July 2021.

DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).