✨ Medicine Distribution Consents




4 MARCH 2010 NEW ZEALAND GAZETTE, No. 25 567

Product: Topamax
Active Ingredient: Topiramate 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Cilag AG, Schaffhausen, Switzerland

Product: Topamax
Active Ingredient: Topiramate 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Cilag AG, Schaffhausen, Switzerland

Product: Topamax Sprinkle
Active Ingredient: Topiramate 15mg
Dosage Form: Capsule
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico

Product: Topamax Sprinkle
Active Ingredient: Topiramate 25mg
Dosage Form: Capsule
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico

Product: Topamax Sprinkle
Active Ingredient: Topiramate 50mg
Dosage Form: Capsule
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico

Dated this 24th day of February 2010.

ANTHONY HILL, Deputy Director-General, Regulation and Governance Directorate, 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 set out in the Schedule hereto:

Schedule

Product: Gemcitabine Ebewe
Active Ingredient: Gemcitabine hydrochloride 1140mg equivalent to 1000mg gemcitabine
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: SC Sindan-Pharma Srl, Bucharest, Romania

Product: Gemcitabine Ebewe
Active Ingredient: Gemcitabine hydrochloride 228mg equivalent to 200mg gemcitabine
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: SC Sindan-Pharma Srl, Bucharest, Romania

Product: Irinotecan Ebewe
Active Ingredient: Irinotecan hydrochloride trihydrate 20mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria

Product: Lora-Tabs Allergy & Hayfever
Active Ingredient: Loratadine 10mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Adcock Ingram Limited - A Medreich Group Company, Bangalore, India

Product: Panadol Cold & Flu Hot Lemon & Honey
Active Ingredient: Paracetamol 600mg
Dosage Form: Powder for oral solution
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SmithKline Beecham SA, Madrid, Spain



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2010, No 25





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
24 February 2010
Medicines Act, Consent, Topamax, Topiramate, Janssen-Cilag, Cilag AG
  • Anthony Hill, Deputy Director-General, Regulation and Governance Directorate, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
24 February 2010
Medicines Act, Consent, Gemcitabine Ebewe, Irinotecan Ebewe, Lora-Tabs, Panadol Cold & Flu, Pharmaco (NZ) Limited, Mylan New Zealand Limited, GlaxoSmithKline (NZ) Limited
  • Anthony Hill, Deputy Director-General, Regulation and Governance Directorate, Ministry of Health