Provisional Consent to the Distribution of a New Medicine
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:
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 condition:
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 until 22 January 2023.
Dated this 6th day of July 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on the 11th day of September 2013).