Gazette.govt.nzPursuant 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: | Cosentyx |
| Active Ingredient: | Secukinumab 150mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | Cosentyx |
| Active Ingredient: | Secukinumab 150mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Sandoz GmbH, Langkampfen, Austria |
| Product: | DBL™ Heparin Sodium Injection BP |
| Active Ingredient: | Heparin sodium 1000IU/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Wasserburger Arzneimittelwerk GmbH, Wasserburg, Germany Siegfried Hameln GmbH, Hamelin, Germany |
| Product: | DBL™ Heparin Sodium Injection BP |
| Active Ingredient: | Heparin sodium 5000IU/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Wasserburger Arzneimittelwerk GmbH, Wasserburg, Germany Siegfried Hameln GmbH, Hamelin, Germany |
| Product: | DBL™ Heparin Sodium Injection BP |
| Active Ingredient: | Heparin sodium 25000IU/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Wasserburger Arzneimittelwerk GmbH, Wasserburg, Germany Siegfried Hameln GmbH, Hamelin, Germany |
| Product: | Mupirocin Ointment |
| Active Ingredient: | Mupirocin 20mg/g |
| Dosage Form: | Topical ointment |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | Paul W. Beyvers GmbH, Berlin, Germany |
| Product: | Nucala |
| Active Ingredient: | Mepolizumab 144mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturer: | GlaxoSmithKline Manufacturing SpA, Parma, Italy |
| Product: | Nucala (Pre-filled Pen) |
| Active Ingredient: | Mepolizumab 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturer: | Glaxo Operations UK Limited t/a Glaxo Welcome Operations, Barnard Castle, United Kingdom |
| Product: | Nucala (Pre-filled Syringe) |
| Active Ingredient: | Mepolizumab 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturer: | Glaxo Operations UK Limited t/a Glaxo Welcome Operations, Barnard Castle, United Kingdom |
Dated this 20th day of December 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).