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 medicines set out in the Schedule hereto:
Schedule
Product: | Coversyl |
Active Ingredient: | Perindopril erbumine 2mg |
Dosage Form: | Tablet |
New Zealand Sponsor: | Servier Laboratories Limited |
Manufacturers: | Les Laboratoires Servier Industrie, Gidy, France Servier (Ireland) Industries Limited, Arklow, Ireland |
Note: This consent is given subject to the following conditions: - Provisional consent is to be granted for two 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. |
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Note: This consent is valid for two years from the date of publication of this notice. | |
Product: | Coversyl |
Active Ingredient: | Perindopril erbumine 4mg |
Dosage Form: | Tablet |
New Zealand Sponsor: | Servier Laboratories Limited |
Manufacturers: | Les Laboratoires Servier Industrie, Gidy, France Servier (Ireland) Industries Limited, Arklow, Ireland |
Note: This consent is given subject to the following conditions: - Provisional consent is to be granted for two 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. |
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Note: This consent is valid for two years from the date of publication of this notice. |
Dated this 21st day of January 2021.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).