Medicines Distribution Consent




NEW ZEALAND GAZETTE, No. 71

26 MAY 2011


Product:

I-Losartan potassium & Hydrochlorothiazide
Active Ingredients:

  • Hydrochlorothiazide 12.5mg
  • Losartan potassium 50mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Ipca Pharma (NZ) Pty Limited

Manufacturer:
Ipca Laboratories Limited, Dadra and Nagar Haveli, India


Product:

Losartan Potassium & Hydrochlorothiazide
Active Ingredients:

  • Hydrochlorothiazide 12.5mg
  • Losartan potassium 50mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Ipca Pharma (NZ) Pty Limited

Manufacturer:
Ipca Laboratories Limited, Dadra and Nagar Haveli, India


Product:

Vimovo
Active Ingredients:

  • Esomeprazole magnesium trihydrate 22.3mg equivalent to esomeprazole 20mg
  • Naproxen 500mg

Dosage Form:
Modified release tablet

New Zealand Sponsor:
AstraZeneca Limited

Manufacturer:
Patheon Pharmaceuticals Inc, Ohio, United States of America


Product:

Your Pharmacy Cold & Flu Relief PE
Active Ingredients:

  • Codeine phosphate hemihydrate 6mg
  • Paracetamol 500mg
  • Phenylephrine hydrochloride 5mg

Dosage Form:
Tablet

New Zealand Sponsor:
Orion Laboratories (NZ) Limited

Manufacturer:
PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand


Product:

Your Pharmacy Pain Relief Plus
Active Ingredients:

  • Codeine phosphate hemihydrate 9.75mg
  • Doxylamine succinate 5mg
  • Paracetamol 450mg

Dosage Form:
Tablet

New Zealand Sponsor:
Orion Laboratories (NZ) Limited

Manufacturer:
PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand


Dated this 19th day of May 2011.

PAT TUOHY, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of 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 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:

DuoTrav
Active Ingredients:

  • Timolol maleate 6.8mg/mL equivalent to timolol 5mg/mL
  • Travoprost 40µg/mL

Dosage Form:
Eye drops, solution

New Zealand Sponsor:
Alcon New Zealand Limited

Manufacturers:

  • Alcon Laboratories Inc, Texas, United States of America
  • SA Alcon Couvreur NV, Puurs, Belgium

Product:

Lucrin
Active Ingredient:

  • Leuprorelin acetate 5mg/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
Abbott Laboratories (NZ) Limited

Manufacturer:
Famar L’Aigle, Saint Remy-sur-Avre, France



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2011, No 71





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines under the Medicines Act 1981 (continued from previous page)

🏥 Health & Social Welfare
19 May 2011
Medicines, Distribution, Consent, New Zealand Sponsor, Manufacturer
  • PAT TUOHY, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health