✨ Medicines Act Consent




24 AUGUST 2006

NEW ZEALAND GAZETTE, No. 100

2969

Health

Medicines Act 1981

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 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

Manufacturers: AstraZeneca AB, Sodertalje, Sweden

AstraZeneca Pty Limited, North Ryde, New South Wales, Australia

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).

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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2006, No 100


Gazette.govt.nz PDF NZ Gazette 2006, No 100





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of Changed Medicines

πŸ₯ Health & Social Welfare
20 August 2006
Medicines, Distribution, Consent, Medicines Act 1981, Changed Medicines
  • DON MATHESON, Deputy Director-General, Public Health