✨ Consent to Distribution of New Medicines




24 MAY

NEW ZEALAND GAZETTE

1177

Product:
Optazine
Active Ingredient(s):
Naphazoline hydrochloride 0.5mg/mL
Dosage Form:
Eye drops, solution
New Zealand Sponsor:
Whitehall Consumer Healthcare (NZ) Limited
Manufacturer(s):
Sigma Pharmaceuticals Pty Limited, (Creams and liquids man. site), Clayton, Victoria, Australia

Product:
Sancap
Active Ingredient(s):
Captopril 12.5mg
Dosage Form:
Tablet
New Zealand Sponsor:
Novartis New Zealand Limited
Manufacturer(s):
Losan Pharma GmbH, Neuenberg, Germany

Product:
Sancap
Active Ingredient(s):
Captopril 25mg
Dosage Form:
Tablet
New Zealand Sponsor:
Novartis New Zealand Limited
Manufacturer(s):
Losan Pharma GmbH, Neuenberg, Germany

Product:
Sancap
Active Ingredient(s):
Captopril 50mg
Dosage Form:
Tablet
New Zealand Sponsor:
Novartis New Zealand Limited
Manufacturer(s):
Losan Pharma GmbH, Neuenberg, Germany

Product:
Siterone
Active Ingredient(s):
Cyproterone acetate 50mg
Dosage Form:
Tablet
New Zealand Sponsor:
REX Medical Limited
Manufacturer(s):
Cipla Limited, Patalganga Industrial Area, District - Raigad (Maharashtra), India

Dated this 15th day of May 2001.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).

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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:
Acnederm Medicated Lotion
Active Ingredient(s):
Azelaic acid 20%w/w
Dosage Form:
Lotion
New Zealand Sponsor:
Douglas Pharmaceuticals Limited
Manufacturer(s):
Ego Pharmaceuticals Pty Limited, Braeside, Victoria, Australia

Product:
Benadryl Dry Cough & Nasal Congestion
Active Ingredient(s):
Dextromethorphan hydrobromide 2mg/mL
Pseudoephedrine hydrochloride 6mg/mL
Dosage Form:
Syrup
New Zealand Sponsor:
Warner Lambert Consumer Group Div. of Pfizer Laboratories Limited
Manufacturer(s):
Parke Davis Pty Limited, Caringbah, Sydney, New South Wales, Australia

Product:
Cellufresh
Active Ingredient(s):
Carmellose sodium 5mg/mL
Dosage Form:
Eye drops, solution
New Zealand Sponsor:
Allergan New Zealand Limited
Manufacturer(s):
Allergan Optical, Allergan Inc., Waco, Texas, United States of America

Product:
Diflucan
Active Ingredient(s):
Fluconazole 10mg/mL
Dosage Form:
Powder for oral suspension
New Zealand Sponsor:
Pfizer Laboratories Limited
Manufacturer(s):
Pfizer S.A., de Poce-sur-cisse, Amboise Cedex, France

Product:
Diflucan
Active Ingredient(s):
Fluconazole 40mg/mL
Dosage Form:
Powder for oral suspension
New Zealand Sponsor:
Pfizer Laboratories Limited
Manufacturer(s):
Pfizer S.A., de Poce-sur-cisse, Amboise Cedex, France



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2001, No 52


Gazette.govt.nz PDF NZ Gazette 2001, No 52





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
15 May 2001
Medicines Act 1981, new medicines, distribution consent, Optazine, Sancap, Siterone
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines Act 1981, new medicines, distribution consent, Acnederm Medicated Lotion, Benadryl Dry Cough & Nasal Congestion, Cellufresh, Diflucan