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).