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 set out in the Schedule hereto:
Schedule
| Product: | Adynovate |
| Active Ingredient: | Rurioctocog alfa pegol 750IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Takeda New Zealand Limited |
| Manufacturer: | Baxalta Manufacturing SARL, Neuchatel, Switzerland |
| Product: | Adynovate |
| Active Ingredient: | Rurioctocog alfa pegol 1500IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Takeda New Zealand Limited |
| Manufacturer: | Baxalta Manufacturing SARL, Neuchatel, Switzerland |
| Product: | Adynovate |
| Active Ingredient: | Rurioctocog alfa pegol 3000IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Takeda New Zealand Limited |
| Manufacturer: | Baxalta Manufacturing SARL, Neuchatel, Switzerland |
| Product: | PIQRAY |
| Active Ingredient: | Alpelisib 150mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: Component 1: |
PIQRAY |
| Active Ingredient: | Alpelisib 50mg |
| Dosage Form: Component 2: |
Film coated tablet |
| Active Ingredient: | Alpelisib 200mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | PIQRAY |
| Active Ingredient: | Alpelisib 200mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | Slenyto |
| Active Ingredient: | Melatonin 1mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | SwissCo Services AG, Sisseln, Switzerland Dragenopharm, Apotheker Puschl GmbH & Co. KG, Tittmoning, Germany Iberfar - Industria Farmaceutica S.A., Barcarena, Portugal |
| Product: | Slenyto |
| Active Ingredient: | Melatonin 5mg |
| Dosage Form: | Modified release tablet |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | SwissCo Services AG, Sisseln, Switzerland Dragenopharm, Apotheker Puschl GmbH & Co. KG, Tittmoning, Germany Iberfar - Industria Farmaceutica S.A., Barcarena, Portugal |
Dated this 29th day of July 2021.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).