Medicine Approvals




14 FEBRUARY 2013 NEW ZEALAND GAZETTE, No. 15

497

Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 27.32mg equivalent to erlotinib 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Roche SpA, Milan, Italy
Kremers Urban Pharmaceuticals Inc, Indiana, United States of America

Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 109.29mg equivalent to erlotinib 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Roche SpA, Milan, Italy
Kremers Urban Pharmaceuticals Inc, Indiana, United States of America

Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 163.93mg equivalent to erlotinib 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Roche SpA, Milan, Italy
Kremers Urban Pharmaceuticals Inc, Indiana, United States of America

Dated this 7th day of February 2013.

DR DON MACKIE, 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 set out in the Schedule hereto:

Schedule

Product: Canesten Fluconazole Capsule
Active Ingredient: Fluconazole 150mg
Dosage Form: Capsule
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India

Product: Canesten Fluconazole Capsule & Clotrimazole Cream Duo (Combination Product)
Canesten Fluconazole Capsule dose:
Active Ingredient: Fluconazole 150mg
Dosage Form: Capsule
Clotrimazole dose:
Active Ingredient: Clotrimazole 10mg/g
Dosage Form: Topical cream
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturers: Kern Pharma SL, Barcelona, Spain
Intas Pharmaceuticals Limited, Gujarat, India
Encube Ethicals Private Limited, Goa, India

Product: Eylea
Active Ingredient: Aflibercept 40mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Regeneron Pharmaceuticals Inc, New York, United States of America

Product: Victrelis® Pegatron® Combination Therapy (Combination Product)
Victrelis dose:
Active Ingredient: Boceprevir 200mg
Dosage Form: Capsule
PEG-Intron dose:
Active Ingredient: Peginterferon alfa-2b 50mcg
Dosage Form: Powder for injection with diluent



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2013, No 15





✨ LLM interpretation of page content

🏥 Consent to Distribution of Tarceva

🏥 Health & Social Welfare
7 February 2013
Medicines, Approval, Distribution, Tarceva, Erlotinib
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

🏥 Consent to Distribution of New Medicines

🏥 Health & Social Welfare
Medicines, Approval, Distribution, Canesten, Eylea, Pegatron