Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product: | Lescol |
Active Ingredient: | Fluvastatin sodium 21.06mg equivalent to fluvastatin 20mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | Novartis New Zealand Limited |
Manufacturer: | Novartis Farmaceutica SA, Barcelona, Spain |
Product: | Lescol |
Active Ingredient: | Fluvastatin sodium 42.12mg equivalent to fluvastatin 40mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | Novartis New Zealand Limited |
Manufacturer: | Novartis Farmaceutica SA, Barcelona, Spain |
Product: | Lescol XL |
Active Ingredient: | Fluvastatin sodium 84.24mg equivalent to fluvastatin 80mg |
Dosage Form: | Modified release tablet |
New Zealand Sponsor: | Novartis New Zealand Limited |
Manufacturers: | Novartis Farmaceutica SA, Barcelona, Spain Pfizer Ireland Pharmaceuticals, Newbridge, Ireland |
Dated this 9th day of August 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).