✨ Consent to Distribution of New Medicines




NEW ZEALAND GAZETTE, No. 16

17 FEBRUARY 2011

Product:
Fiorinal Tension Headache (Pharmacy Only)
Active Ingredients
Caffeine 65mg
Paracetamol 500mg
Dosage Form:
Tablet
New Zealand Sponsor:
Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturer:
Novartis Consumer Health Inc., Nebraska, United States of America

Product:
Fiorinal Tension Headache (General Sale)
Active Ingredients:
Caffeine 65mg
Paracetamol 500mg
Dosage Form:
Tablet
New Zealand Sponsor:
Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturer:
Novartis Consumer Health Inc., Nebraska, United States of America

Product:
Lincocin
Active Ingredient:
Lincomycin hydrochloride monohydrate 340.26mg/mL equivalent to lincomycin 300mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Pfizer New Zealand Limited
Manufacturers:
Pfizer Manufacturing Belgium NV, Puurs, Belgium
Pharmacia & Upjohn Company, Michigan, United States of America

Product:
Midaccord
Active Ingredient:
Midazolam 1mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Accord Healthcare NZ Limited
Manufacturer:
Intas Pharmaceuticals Limited, Ahmedabad, India

Product:
Midaccord
Active Ingredient:
Midazolam 5mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Accord Healthcare NZ Limited
Manufacturer:
Intas Pharmaceuticals Limited, Ahmedabad, India

Product:
Your Pharmacy Dry Cough Syrup
Active Ingredient:
Dextromethorphan hydrobromide, anhydrous 1mg
Dosage Form:
Solution
New Zealand Sponsor:
Orion Laboratories (NZ) Limited
Manufacturer:
PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand

Dated this 10th day of February 2011.

BARBARA PHILLIPS, Acting Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

go960

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 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:
Pradaxa
Active Ingredient:
Dabigatran etexilate 86.48mg equivalent to 75mg free base
Dosage Form:
Capsule
New Zealand Sponsor:
Boehringer Ingelheim (NZ) Limited
Manufacturers:
Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Pradaxa
Active Ingredient:
Dabigatran etexilate 126.83mg equivalent to 110mg free base
Dosage Form:
Capsule
New Zealand Sponsor:
Boehringer Ingelheim (NZ) Limited
Manufacturers:
Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Dated this 10th day of February 2011.

BARBARA PHILLIPS, Acting Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

go961



Next Page →



Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2011, No 16





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
10 February 2011
Medicines Act, New Medicines, Fiorinal, Lincocin, Midaccord, Pradaxa
  • BARBARA PHILLIPS, Acting Deputy Director-General, Population Health Directorate, Ministry of Health