A corrigendum to this notice was published on 9 September 2022, Notice No. 2022-go3843.

Notice Title

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:

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 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).