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: | Jakavi |
| Active Ingredient: | Ruxolitinib phosphate 6.6mg equivalent to ruxolitinib 5mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | Jakavi |
| Active Ingredient: | Ruxolitinib phosphate 13.2mg equivalent to ruxolitinib 10mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | Jakavi |
| Active Ingredient: | Ruxolitinib phosphate 19.8mg equivalent to ruxolitinib 15mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | Jakavi |
| Active Ingredient: | Ruxolitinib phosphate 26.4mg equivalent to ruxolitinib 20mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| 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 11th day of November 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).