✨ Medicines Distribution Consent




NEW ZEALAND GAZETTE, No. 113

28 JULY 2011

Product:
Dimetapp PE Sinus Pain + Allergy

Active Ingredients:

  • Chlorphenamine maleate 2mg
  • Paracetamol 500mg
  • Phenylephrine hydrochloride 5mg

Dosage Form:
Tablet

New Zealand Sponsor:
Pfizer New Zealand Limited

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


Product:
Healon Endocoat

Active Ingredient:
Sodium hyaluronate 30mg/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
AMO Australia Pty Limited

Manufacturer:
Life Core Biomedical LLC, Minnesota, United States of America


Product:
Iressa

Active Ingredient:
Gefitinib 250mg

Dosage Form:
Coated tablet

New Zealand Sponsor:
AstraZeneca Limited

Manufacturer:
AstraZeneca UK Limited, Cheshire, United Kingdom


Product:
OPTIVE Sensitive

Active Ingredients:

  • Carmellose sodium 0.5%w/v
  • Glycerol 0.9%w/v

Dosage Form:
Eye drops, solution

New Zealand Sponsor:
Allergan New Zealand Limited

Manufacturer:
Allergan Pharmaceuticals Ireland, Westport, Ireland


Product:
Zaprone

Active Ingredient:
Ziprasidone hydrochloride monohydrate 22.487mg equivalent to ziprasidone 20mg

Dosage Form:
Capsule

New Zealand Sponsor:
Mylan New Zealand Limited

Manufacturer:
Matrix Laboratories Limited, Maharashtra State, India


Product:
Zaprone

Active Ingredient:
Ziprasidone hydrochloride monohydrate 44.974mg equivalent to ziprasidone 40mg

Dosage Form:
Capsule

New Zealand Sponsor:
Mylan New Zealand Limited

Manufacturer:
Matrix Laboratories Limited, Maharashtra State, India


Product:
Zaprone

Active Ingredient:
Ziprasidone hydrochloride monohydrate 67.461mg equivalent to ziprasidone 60mg

Dosage Form:
Capsule

New Zealand Sponsor:
Mylan New Zealand Limited

Manufacturer:
Matrix Laboratories Limited, Maharashtra State, India


Product:
Zaprone

Active Ingredient:
Ziprasidone hydrochloride monohydrate 89.948mg equivalent to ziprasidone 80mg

Dosage Form:
Capsule

New Zealand Sponsor:
Mylan New Zealand Limited

Manufacturer:
Matrix Laboratories Limited, Maharashtra State, India

Dated this 22nd day of July 2011.

MARK JACOBS, 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 a New Related Product

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new related product set out in the Schedule hereto:

Schedule

Product:
Arrow - Calcium

Active Ingredient:
Limestone, ground 1300mg equivalent to calcium carbonate 1222–1306.5mg, equivalent to elemental calcium 500mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Arrow Pharmaceuticals (NZ) Limited

Manufacturer:
Delavau LLC, Pennsylvania, United States of America



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2011, No 113





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of New Medicines

πŸ₯ Health & Social Welfare
22 July 2011
Medicines Act 1981, New medicines, Distribution consent, Pharmaceuticals
  • MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

πŸ₯ Consent to Distribution of New Related Product

πŸ₯ Health & Social Welfare
Medicines Act 1981, Related product, Distribution consent, Pharmaceuticals
  • Minister of Health