Find a specific notice:

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

Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of a New Medicine

Publication Date
9 Jun 2022

Tags

Companies Act Provisional consent to the distribution of new medicines Health

Notice Number

2022-go2279
Title
View PDF
File Type and Size
PDF (34 KB)

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).