Gazette.govt.nzPursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
| Product: | Jemperli |
| Active Ingredient: | Dostarlimab 50mg/mL |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturer: | Ajinomoto Althea Inc, California, United States of America |
Note: This consent is given subject to the following conditions:
The New Zealand Sponsor must fulfil the following obligations within the timeline specified, the date of which may be altered by mutual agreement with Medsafe:
- Provide confirmatory efficacy and safety data from the Ruby study 4010-03-001. Due date: 31 December 2023.
- Submit PBRERs as they become available.
Note: This consent is valid for two years from the date of publication of this notice.
| Product: | Oxybutynin |
| Active Ingredient: | Oxybutynin hydrochloride 5mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Alchemy Health Limited |
| Manufacturer: | Hemofarm d.o.o., Banja Luka, Bosnia and Herzegovina |
Note: This consent is given subject to the following condition:
The medicine may only be marketed or distributed when no other oxybutynin hydrochloride tablet medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet PHARMAC supply obligations.
Note: This consent is valid for two years from the date of publication of this notice.
Dated this 30th day of June 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).