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, Carlow, Ireland |
| Product: | Nicotrol |
| Active Ingredient: | Nicotine polacrilex 10mg equivalent to nicotine 2mg |
| Dosage Form: | Chewing gum |
| New Zealand Sponsor: | JNTL Consumer Health (New Zealand) Limited |
| Manufacturer: | McNeil AB, Helsingborg, Sweden |
| Product: | Nicotrol |
| Active Ingredient: | Nicotine polacrilex 20mg equivalent to nicotine 4mg |
| Dosage Form: | Chewing gum |
| New Zealand Sponsor: | JNTL Consumer Health (New Zealand) Limited |
| Manufacturer: | McNeil AB, Helsingborg, Sweden |
| Product: | Skyrizi |
| Active Ingredient: | Risankizumab 90.36mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | AbbVie Limited |
| Manufacturers: | Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany AbbVie Biotechnology Limited, Barceloneta, Puerto Rico |
| Product: | Zeposia (Combination product) |
| Component 1 | |
| Active Ingredient: | Ozanimod 0.23mg equivalent to Ozanimod hydrochloride 0.25mg |
| Dosage Form: | Capsule |
| Component 2 | |
| Active Ingredient: | Ozanimod 0.46mg equivalent to Ozanimod hydrochloride 0.5mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Celgene Limited |
| Manufacturers: | Patheon Inc, Mississauga, Canada Celgene International Sarl, Boudry, Switzerland |
| Product: | Zeposia |
| Active Ingredient: | Ozanimod 0.92mg equivalent to Ozanimod hydrochloride 1mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Celgene Limited |
| Manufacturers: | Patheon Inc, Mississauga, Canada Celgene International Sarl, Boudry, Switzerland |
Dated this 19th day of May 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).