Notice Type
Departmental
Consent to the Distribution of Changed Medicines Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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(s): Fluvastatin sodium 21.06 mg equivalent to 20 mg fluvastatin. Dosage Form: Capsule. NZ Sponsor: Novartis New Zealand Limited. Manufacturer(s): Novartis Farmaceutica S.A., Barbera del Valles, Barcelona, Spain. Product: Lescol. Active Ingredient(s): Fluvastatin sodium 42.12 mg equivalent to 40 mg fluvastatin. Dosage Form: Capsule. NZ Sponsor: Novartis New Zealand Limited. Manufacturer(s): Novartis Farmaceutica S.A., Barbera del Valles, Barcelona, Spain. Product: Plendil ER. Active Ingredient(s): Felodipine 10 mg. Dosage Form: Modified release tablet. NZ Sponsor: AstraZeneca Limited. Manufacturer(s): Astra Pharmaceutical Production AB, Sodertalje, Sweden.[ql] Astra Pharmaceuticals Pty Limited, North Ryde, New South Wales, Australia. Product: Plendil ER. Active Ingredient(s): Felodipine 2.5 mg. Dosage Form: Modified release tablet. NZ Sponsor: AstraZeneca Limited. Manufacturer(s): Astra Pharmaceutical Production AB, Sodertalje, Sweden.[ql] Astra Pharmaceuticals Pty Limited, North Ryde, New South Wales, Australia. Product: Plendil ER. Active Ingredient(s): Felodipine 5 mg. Dosage Form: Modified release tablet. NZ Sponsor: AstraZeneca Limited. Manufacturer(s): Astra Pharmaceutical Production AB, Sodertalje, Sweden.[ql] Astra Pharmaceuticals Pty Limited, North Ryde, New South Wales, Australia. Product: Prograf. Active Ingredient(s): Tacrolimus 1 mg. Dosage Form: Capsule. NZ Sponsor: Janssen-Cilag Pty Limited. Manufacturer(s): Fujisawa Ireland Limited, Killorglin, Co Kerry, Eire. Product: Prograf. Active Ingredient(s): Tacrolimus 5 mg. Dosage Form: Capsule. NZ Sponsor: Janssen-Cilag Pty Limited. Manufacturer(s): Fujisawa Ireland Limited, Killorglin, Co Kerry, Eire. Product: Prograf. Active Ingredient(s): Tacrolimus 5 mg/mL. Dosage Form: Solution for infusion. NZ Sponsor: Janssen-Cilag Pty Limited. Manufacturer(s): Fujisawa Ireland Limited, Killorglin, Co Kerry, Eire. Dated this 9th day of August 1999. G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).
Publication Date
12 Aug 1999

Notice Number

1999-go5853

Page Number

2249