Gazette.govt.nzPursuant 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).