β¨ 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 1222β1306.5mg, 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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β¨ LLM interpretation of page content
π₯ Consent to Distribution of New Medicines
π₯ Health & Social Welfare22 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
π₯ Consent to Distribution of New Related Product
π₯ Health & Social WelfareMedicines Act 1981, Related product, Distribution consent, Pharmaceuticals
- Minister of Health
NZ Gazette 2011, No 113