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: | 5% Glucose |
| Active Ingredient: | Glucose monohydrate 5.5%w/v equivalent to glucose 5%w/v |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | Baxter Healthcare Limited |
| Manufacturer: | Bieffe Medital SA, Sabinanigo, Spain |
| Product: | Co-Diovan |
| Active Ingredients: | Hydrochlorothiazide 12.5mg Valsartan 80mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Novartis Farma SpA, Torre Annunziata, Italy |
| Product: | Co-Diovan |
| Active Ingredients: | Hydrochlorothiazide 12.5mg Valsartan 160mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Novartis Farma SpA, Torre Annunziata, Italy |
| Product: | Co-Diovan |
| Active Ingredients: | Hydrochlorothiazide 12.5mg Valsartan 320mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Novartis Farma SpA, Torre Annunziata, Italy |
| Product: | Co-Diovan |
| Active Ingredients: | Hydrochlorothiazide 25mg Valsartan 160mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Novartis Farma SpA, Torre Annunziata, Italy |
| Product: | Co-Diovan |
| Active Ingredients: | Hydrochlorothiazide 25mg Valsartan 320mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Novartis Farma SpA, Torre Annunziata, Italy |
| Product: | Diovan |
| Active Ingredient: | Valsartan 40mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Novartis Farmaceutica SA, Barcelona, Spain |
| Product: | Diovan |
| Active Ingredient: | Valsartan 80mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Novartis Farmaceutica SA, Barcelona, Spain |
| Product: | Diovan |
| Active Ingredient: | Valsartan 160mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Novartis Farmaceutica SA, Barcelona, Spain |
| Product: | Diovan |
| Active Ingredient: | Valsartan 320mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Stein AG, Stein, Switzerland Novartis Farmaceutica SA, Barcelona, Spain |
| Product: | Herzuma |
| Active Ingredient: | Trastuzumab 150mg |
| Dosage Form: | Powder for infusion concentrate |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturer: | Celltrion Inc., Incheon, South Korea |
| Product: | Herzuma |
| Active Ingredient: | Trastuzumab 440mg |
| Dosage Form: | Powder for infusion concentrate with diluent |
| New Zealand Sponsor: | Celltrion Healthcare New Zealand Limited |
| Manufacturer: | Celltrion Inc., Incheon, South Korea |
| Product: | Nuwiq |
| Active Ingredient: | Simoctocog alfa 250IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Octapharma New Zealand Limited |
| Manufacturers: | Octapharma AB, Stockholm, Sweden Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | Nuwiq |
| Active Ingredient: | Simoctocog alfa 500IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Octapharma New Zealand Limited |
| Manufacturers: | Octapharma AB, Stockholm, Sweden Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | Nuwiq |
| Active Ingredient: | Simoctocog alfa 1000IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Octapharma New Zealand Limited |
| Manufacturers: | Octapharma AB, Stockholm, Sweden Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | Nuwiq |
| Active Ingredient: | Simoctocog alfa 2000IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Octapharma New Zealand Limited |
| Manufacturers: | Octapharma AB, Stockholm, Sweden Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | Remifentanil-AFT |
| Active Ingredient: | Remifentanil hydrochloride 1.097mg equivalent to remifentanil 1mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Laboratorio Reig Jofre SA, Barcelona, Spain |
| Product: | Remifentanil-AFT |
| Active Ingredient: | Remifentanil hydrochloride 2.194mg equivalent to remifentanil 2mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Laboratorio Reig Jofre SA, Barcelona, Spain |
| Product: | Soliris |
| Active Ingredient: | Eculizumab 300mg |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Patheon Italia SpA, Milan, Italy Alexion Pharma International Operations Unlimited Company, Athlone, Ireland |
Dated this 29th day of September 2020.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).