Notice Title

Renewal of Provisional Consent to the Distribution of Medicines

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:

Schedule

Product: Coversyl
Active Ingredient: Perindopril erbumine 2mg
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 2 years to address an urgent shortage in the market.
  • 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 renewed consent is valid for two years from 22 January 2023.

Product: Coversyl
Active Ingredient: Perindopril erbumine 4mg
Dosage Form: Tablet
New Zealand Sponsor: Servier Laboratories NZ Limited
Manufactures: 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 2 years to address an urgent shortage in the market.
  • 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 renewed consent is valid for two years from 22 January 2023.

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 2 years to address an urgent shortage in the market.
  • 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 renewed consent is valid for two years from 22 January 2023.

Dated this 19th day of January 2023.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).