Pursuant 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 medicine set out in the Schedule hereto:
Schedule
Product: | Coversyl |
Active Ingredient: | Perindopril erbumine 8mg |
Dosage Form: | Tablet |
New Zealand Sponsor: | Servier Laboratories NZ Limited |
Manufacturers: | Servier (Ireland) Industries Limited, Arklow, Ireland Les Laboratoires Servier Industrie, Gidy, France |
Note: This consent is given subject to the following conditions:
- Provisional consent is to be granted for a period of time such that it expires on 22 January 2023.
- The medicine may only be marketed or distributed when no other perindopril erbumine medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.
Note: This consent is valid for 8 months from the date of publication of this notice.
Dated this 8th day of June 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).