✨ Consent to Distribution of New Medicines




16 MARCH 2006

NEW ZEALAND GAZETTE, No. 25

671

Dated this 9th day of March 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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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:
Apo-Paroxetine

Active Ingredient:
Paroxetine hydrochloride 22.2mg equivalent to 20mg paroxetine base

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Apotex NZ Limited

Manufacturer:
Apotex Inc, Weston, Ontario, Canada

Product:
Calcium Folinate Ebewe

Active Ingredient:
Calcium folinate pentahydrate 12.71mg/mL equivalent to 10mg/mL folinic acid

Dosage Form:
Concentrate for injection

New Zealand Sponsor:
InterPharma Pty Limited

Manufacturer:
EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria

Product:
Fuzeon

Active Ingredient:
Enfuvirtide 108mg

Dosage Form:
Powder for injection

Active Ingredient:
Water for injection

Dosage Form:
Diluent

New Zealand Sponsor:
Roche Products (New Zealand) Limited

Manufacturers:
F Hoffmann-La Roche AG, Basel, Switzerland
Pfizer Inc, Kalamazoo, Michigan, United States of America
Roche Diagnostics GmbH, Mannheim, Germany

Product:
Motrig

Active Ingredient:
Lamotrigine 100mg

Dosage Form:
Chewable/dispersible tablet

New Zealand Sponsor:
REX Medical Limited

Manufacturer:
Cipla Limited, Patalganga Industrial Area, District Raigad, (Maharashtra), India

Product:
Motrig

Active Ingredient:
Lamotrigine 200mg

Dosage Form:
Chewable/dispersible tablet

New Zealand Sponsor:
REX Medical Limited

Manufacturer:
Cipla Limited, Patalganga Industrial Area, District Raigad, (Maharashtra), India

Product:
Motrig

Active Ingredient:
Lamotrigine 25mg

Dosage Form:
Chewable/dispersible tablet

New Zealand Sponsor:
REX Medical Limited

Manufacturer:
Cipla Limited, Patalganga Industrial Area, District Raigad, (Maharashtra), India

Product:
Motrig

Active Ingredient:
Lamotrigine 50mg

Dosage Form:
Chewable/dispersible tablet

New Zealand Sponsor:
REX Medical Limited

Manufacturer:
Cipla Limited, Patalganga Industrial Area, District Raigad, (Maharashtra), India

Product:
Rennie

Active Ingredients:
Calcium carbonate 680mg
Heavy magnesium carbonate 80mg

Dosage Form:
Chewable tablet

New Zealand Sponsor:
Bayer New Zealand Limited

Manufacturer:
Laboratoires Roche Nicholas SA, Gaillard, France

Product:
Reyataz

Active Ingredient:
Atazanavir sulfate 113.9mg equiv to 100mg atazanavir

Dosage Form:
Capsule

New Zealand Sponsor:
Bristol-Myers Squibb (NZ) Company

Manufacturer:
Bristol-Myers Squibb Company, Evansville, Indiana, United States of America



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2006, No 25


Gazette.govt.nz PDF NZ Gazette 2006, No 25





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
9 March 2006
Medicines Act, Distribution Consent, New Medicines, Pharmaceutical Products
  • DON MATHESON, Deputy Director-General, Public Health