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: | Bexsero |
| Active Ingredients: | Neisseria meningitidis group B factor H binding protein fusion protein 50mcg Neisseria meningitidis group B neisseria adhesin A protein 50mcg Neisseria meningitidis group B neisseria heparin binding antigen fusion protein 50mcg Neisseria meningitidis sergroup B outer membrane vesicles 25mcg |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturer: | GlaxoSmithKline Vaccines SRL, Sovicille, Italy |
| Product: | Clopidogrel Multichem |
| Active Ingredient: | Clopidogrel besilate 112.1mg equivalent to clopidogrel 75mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Multichem NZ Limited |
| Manufacturers: | Pharmathen SA, Pallini, Greece Boehringer Ingelheim Hellas Single Member S.A., Koropi, Greece Pharmathen International SA, Rodopi, Greece |
| Product: | Fragmin |
| Active Ingredient: | Dalteparin sodium 10000IU/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Pfizer Manufacturing Belgium NV, Puurs, Belgium |
| Product: | Fragmin |
| Active Ingredient: | Dalteparin sodium 12500IU/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Pfizer Manufacturing Belgium NV, Puurs, Belgium Catalent France Limoges SAS, Limoges, France |
| Product: | Fragmin |
| Active Ingredient: | Dalteparin sodium 25000IU/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Pfizer Manufacturing Belgium NV, Puurs, Belgium Catalent France Limoges SAS, Limoges, France |
| Product: | Gazyva |
| Active Ingredient: | Obinutuzumab 1000mg |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Roche Products (NZ) Limited |
| Manufacturer: | Roche Diagnostics GmbH, Mannheim, Germany |
| Product: | Keytruda |
| Active Ingredient: | Pembrolizumab 25mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturer: | MSD International GmbH t/a MSD Ireland (Carlow), Carlow, Ireland |
Dated this 19th day of July 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).