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 XL
Active Ingredient: Fluvastatin sodium 84.24mg equivalent to 80mg fluvastatin
Dosage Form: Modified release tablet
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturers: Novartis Farmaceutica SA, Barbera del Valles, Barcelona, Spain
Novartis Pharma Stein AG, Stein, Switzerland
Product: Lescol
Active Ingredient: Fluvastatin sodium 21.06mg equivalent to fluvastatin 20mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Novartis Farmaceutica SA, Barbera del Valles, Barcelona, Spain
Product: Lescol
Active Ingredient: Fluvastatin sodium 42.12mg equivalent to fluvastatin 40mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer: Novartis Farmaceutica SA, Barbera del Valles, Barcelona, Spain
Product: Naropin
Active Ingredient: Ropivacaine hydrochloride monohydrate 10.6mg/mL equiv to 10mg/mL Ropivacaine hydrochloride anhydrous
Dosage Form: Solution for injection
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca AB, Sodertalje, Sweden
AstraZeneca Pty Limited, North Ryde, New South Wales, Australia
Product: Naropin
Active Ingredient: Ropivacaine hydrochloride monohydrate 2.12mg/mL equivalent to 2mg/mL Ropivacaine hydrochloride anhydrous
Dosage Form: Solution for injection
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca AB, Kvarnbergagatan 12, Sodertalje, Sweden
AstraZeneca Pty Limited, North Ryde, New South Wales, Australia
NPBI BV, Emmer-Compascuum, The Netherlands
Product: Naropin
Active Ingredient: Ropivacaine hydrochloride monohydrate 5.29mg/mL equiv to 5mg/mL Ropivacaine hydrochloride anhydrous
Dosage Form: Solution for injection
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden
Product: Naropin
Active Ingredient: Ropivacaine hydrochloride monohydrate 7.93mg/mL equiv to 7.5mg/mL Ropivacaine hydrochloride anhydrous
Dosage Form: Solution for injection
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca AB, Sodertalje, Sweden
AstraZeneca Pty Limited, North Ryde, New South Wales, Australia
Dated this 20th day of August 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).