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:
Schedule
Product: | Dovato 50/300 |
Active Ingredients: | Dolutegravir sodium 52.6mg equivalent to dolutegravir 50mg Lamivudine 300mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
Manufacturers: | Glaxo Wellcome SA, Burgos, Spain GlaxoSmithKline LLC, North Carolina, United States of America |
Product: | Oncaspar |
Active Ingredient: | Pegaspargase 3750U |
Dosage Form: | Powder for injection |
New Zealand Sponsor: | Servier Laboratories NZ Ltd |
Manufacturer: | Lyophilization Services of New England Inc, New Hampshire, United States of America |
Dated this 8th day of December 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).