✨ Medicines Distribution Consents




NEW ZEALAND GAZETTE

No. 161

Product:
M-Enalapril
Active Ingredient(s):
Enalapril maleate 10mg
Dosage Form:
Tablet
New Zealand Sponsor:
Multichem Laboratories Limited
Manufacturer(s):
Wockhardt Limited, Chikalthana, Aurangabad, Maharashatra State, India

Product:
M-Enalapril
Active Ingredient(s):
Enalapril maleate 20mg
Dosage Form:
Tablet
New Zealand Sponsor:
Multichem Laboratories Limited
Manufacturer(s):
Wockhardt Limited, Chikalthana, Aurangabad, Maharashatra State, India

Product:
M-Enalapril
Active Ingredient(s):
Enalapril maleate 5mg
Dosage Form:
Tablet
New Zealand Sponsor:
Multichem Laboratories Limited
Manufacturer(s):
Wockhardt Limited, Chikalthana, Aurangabad, Maharashatra State, India

Product:
Redoxon Double Action
Active Ingredient(s):
Ascorbic acid 200mg
Sodium ascorbate 337.4mg
Zinc citrate 16mg equivalent to 5mg zinc
Dosage Form:
Chewable tablet
New Zealand Sponsor:
Roche Consumer Health, Division of Roche Products (N Z) Limited
Manufacturer(s):
Roche Products Limited (trading as Roche Consumer Health), Welwyn Garden City, Hertfordshire, United Kingdom

Dated this 21st day of November 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).

go8352

Consent to the Distribution of a Changed Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine which was referred to the Minister of Health under the provisions of section 24 (5) of the Act and is set out in the Schedule hereto:

Schedule

Product:
Botox
Active Ingredient(s):
Botulinum A toxin 100U
Dosage Form:
Powder for injection
New Zealand Sponsor:
Allergan New Zealand Limited
Manufacturer(s):
Allergan Berkeley, Berkeley, California, United States of America
Allergan Pharmaceuticals (Ireland) Limited, Westport, County Mayo, Eire
Biological Laboratories Europe, Carrentrila, Ballina, County Mayo, Eire
Northview Pacific Labs, Berkeley, California, United States of America
Pharmacia, Alburquerque, New Mexico, United States of America

Dated this 21st day of November 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).

go8353

Consent to the Distribution of a Changed Medicine

Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the changed medicine which was referred to the Minister of Health under the provisions of section 24 (5) of the Act and is set out in the Schedule hereto:

Schedule

Product:
Xeloda
Active Ingredient(s):
Capecitabine 150mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Roche Products (New Zealand) Limited
Manufacturer(s):
Hoffmann-La Roche Inc, Nutley, New Jersey, United States of America
Roche Products Limited (trading as Roche Consumer Health), Welwyn Garden City, Hertfordshire, United Kingdom

Note: This product has consent that expires on 5 August 2003.



Next Page →



Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2001, No 161


Gazette.govt.nz PDF NZ Gazette 2001, No 161





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of New Medicines

πŸ₯ Health & Social Welfare
21 November 2001
Medicines Act, New Medicines, Distribution Consent, M-Enalapril, Redoxon Double Action, Multichem Laboratories, Roche Consumer Health
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Consent to Distribution of Changed Medicine

πŸ₯ Health & Social Welfare
21 November 2001
Medicines Act, Changed Medicine, Distribution Consent, Botox, Allergan New Zealand Limited
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Provisional Consent to Distribution of Changed Medicine

πŸ₯ Health & Social Welfare
21 November 2001
Medicines Act, Changed Medicine, Provisional Consent, Xeloda, Roche Products (New Zealand) Limited
  • G. R. Boyd, Chief Advisor, Safety and Regulation