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: | Keytruda |
| Active Ingredient: | Pembrolizumab 25mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturer: | MSD International GmbH (Ireland), Carlow, Ireland |
| Product: | Keytruda |
| Active Ingredient: | Pembrolizumab 50mg |
| Dosage Form: | Powder for infusion |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturer: | MSD International GmbH, Innishannon, Ireland |
| Product: | Spiolto Respimat |
| Active Ingredients: | Olodaterol hydrochloride 0.0248%w/v equivalent to olodaterol 2.5mcg per actuation Tiotropium bromide monohydrate 0.0283%w/v equivalent to tiotropium 2.5mcg per actuation |
| Dosage Form: | Solution for inhalation |
| New Zealand Sponsor: | Boehringer Ingelheim (NZ) Limited |
| Manufacturer: | Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany |
Dated this 27th day of January 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).