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: | Alprolix |
| Active Ingredient: | Eftrenonacog alfa 250IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | Alprolix |
| Active Ingredient: | Eftrenonacog alfa 500IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | Alprolix |
| Active Ingredient: | Eftrenonacog alfa 1000IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | Alprolix |
| Active Ingredient: | Eftrenonacog alfa 2000IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | Alprolix |
| Active Ingredient: | Eftrenonacog alfa 3000IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | Alprolix |
| Active Ingredient: | Eftrenonacog alfa 4000IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | NITYR |
| Active Ingredient: | Nitisinone 2mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Orpharma NZ Limited |
| Manufacturers: | Penn Pharmaceutical Services Limited, Tredegar, United Kingdom Rivopharm SA, Manno, Switzerland |
| Product: | NITYR |
| Active Ingredient: | Nitisinone 5mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Orpharma NZ Limited |
| Manufacturers: | Penn Pharmaceutical Services Limited, Tredegar, United Kingdom Rivopharm SA, Manno, Switzerland |
| Product: | NITYR |
| Active Ingredient: | Nitisinone 10mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Orpharma NZ Limited |
| Manufacturers: | Penn Pharmaceutical Services Limited, Tredegar, United Kingdom Rivopharm SA, Manno, Switzerland |
Dated this 18th day of September 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).