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: | Revolade |
| Active Ingredient: | Eltrombopag olamine 31.9mg equivalent to eltrombopag 25mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Glaxo Operations UK Limited t/a Glaxo Wellcome Operations, Ware, United Kingdom Lek Pharmaceuticals d.d., Ljubljana, Slovenia Siegfried Barbera SL, Barcelona, Spain |
| Product: | Revolade |
| Active Ingredient: | Eltrombopag olamine 63.8mg equivalent to eltrombopag 50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Glaxo Operations UK Limited t/a Glaxo Wellcome Operations, Ware, United Kingdom Lek Pharmaceuticals d.d., Ljubljana, Slovenia Siegfried Barbera SL, Barcelona, Spain |
| Product: | Revolade |
| Active Ingredient: | Eltrombopag olamine 95.7mg equivalent to eltrombopag 75mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Glaxo Operations UK Limited t/a Glaxo Wellcome Operations, Ware, United Kingdom Lek Pharmaceuticals d.d., Ljubljana, Slovenia Siegfried Barbera SL, Barcelona, Spain |
| 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 7th day of July 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).