Consent to the Distribution of New Medicines
Pursuant 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:
| 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 |
Note: The application received 9 November 2021 is for the adjuvant treatment for renal cell carcinoma indication.
| 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 |
Note: The application received 15 November 2021 is for the triple-negative breast cancer indications.
| Product: | Sudocrem |
| Active Ingredient: | Zinc oxide 15.29%w/w |
| Dosage Form: | Topical cream |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | Tosara Pharma Limited, Baldoyle, Ireland |
Dated this 14th day of June 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).