New Zealand Gazette – 2009 – No. 16

Page 405

✨ Health Notices

Health

Medicines Act 1981

Consent to the Distribution of New Medicines

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 set out in the Schedule hereto:

Schedule

Product: AMLO
Active Ingredient: Amlodipine besilate 13.87mg equivalent to 10mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Genpharm ULC, Ontario, Canada

Product: AMLO
Active Ingredient: Amlodipine besilate 6.94mg equivalent to 5mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Genpharm ULC, Ontario, Canada

Product: Donezil
Active Ingredient: Donepezil hydrochloride 10mg equivalent to 9.12mg donepezil base
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturers: McDermott Laboratories, t/a Gerard Laboratories, Grange Road, Dublin, Ireland
Merck Farma y Quimica SL, Polígono Merck, Mollet del Vallès, Barcelona, Spain

Product: Donezil
Active Ingredient: Donepezil hydrochloride 5mg equivalent to 4.56mg donepezil base
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturers: McDermott Laboratories, t/a Gerard Laboratories, Grange Road, Dublin, Ireland
Merck Farma y Quimica SL, Polígono Merck, Mollet del Vallès, Barcelona, Spain

Product: Eprex
Active Ingredient: Epoetin alfa 336μg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Ltd
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany

Product: Nurofen Cold & Flu PE Phenylephrine
Active Ingredients: Ibuprofen 200mg
Phenylephrine hydrochloride 5mg equivalent to 4.1mg phenylephrine
Dosage Form: Film coated tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, Nottinghamshire, United Kingdom

Product: Nurofen Zavance 400 Double Strength Tablets
Active Ingredient: Ibuprofen sodium dihydrate 512mg equivalent to Ibuprofen 400mg
Dosage Form: Coated tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, Nottinghamshire, United Kingdom

Dated this 4th day of February 2009.

MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Classification of Medicines

Pursuant to section 106(1) of the Medicines Act 1981, I, Stewart Jessamine, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health, acting under delegated authority, hereby declare the following:

The medicines listed in Schedule 1 to this notice are classified as prescription medicines.
The medicines listed in Schedule 2 to this notice are classified as restricted medicines.
The medicines listed in Schedule 3 to this notice are classified as pharmacy-only medicines.

Gazette.govt.nz — NZ Gazette 2009, No 16

The General Assembly Library (on the right) was completed in 1899 and survived the 1907 fire. Now the oldest remaining original Parliament building, still used as the Parliamentary Library.

✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines

Domain🏥 Health & Social Welfare
Dated4 February 2009
KeywordsMedicines, Distribution, Consent, New Zealand, Sponsor, Manufacturer
👩‍💼 Officials

MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate

🏥 Classification of Medicines

Domain🏥 Health & Social Welfare
KeywordsMedicines, Classification, Prescription, Restricted, Pharmacy-only
👩‍💼 Officials

Stewart Jessamine, Acting Deputy Director-General, Sector Accountability and Funding Directorate

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