Medicine Distribution Consent




NEW ZEALAND GAZETTE, No. 53 — 14 MAY 2015

Product:
Metvix
Active Ingredient:
Methyl aminolevulinate hydrochloride 200mg/g
equivalent to Methyl aminolevulinate 160mg/g
Dosage Form:
Topical cream
New Zealand Sponsor:
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer:
Penn Pharmaceutical Services Limited, Gwent, United Kingdom

Product:
Pegasys RBV (Combination Product)
Component 1
Active Ingredient:
Peginterferon alfa-2a 270mcg/mL
Dosage Form:
Solution for injection
Manufacturers:
F Hoffmann-La Roche Limited, Basel, Switzerland
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
Roche Diagnostics GmbH, Mannheim, Germany

Component 2
Active Ingredient:
Ribavirin 200mg
Dosage Form:
Film coated tablet
Manufacturers:
Hoffmann-La Roche Inc, New Jersey, United States of America
Patheon Inc, Ontario, Canada
New Zealand Sponsor:
Roche Products (NZ) Limited

Product:
Pegasys RBV (Combination Product)
Component 1
Active Ingredient:
Peginterferon alfa-2a 360mcg/mL
Dosage Form:
Solution for injection
Manufacturers:
F Hoffmann-La Roche Limited, Basel, Switzerland
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
Roche Diagnostics GmbH, Mannheim, Germany

Component 2
Active Ingredient:
Ribavirin 200mg
Dosage Form:
Film coated tablet
Manufacturers:
Hoffmann-La Roche Inc, New Jersey, United States of America
Patheon Inc, Ontario, Canada
New Zealand Sponsor:
Roche Products (NZ) Limited

Dated this 8th day of May 2015.

CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

2015-go2797

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:
Ribomustin
Active Ingredient:
Bendamustine hydrochloride 25mg equivalent to Bendamustine 22.7mg
Dosage Form:
Powder for infusion
New Zealand Sponsor:
Janssen-Cilag (New Zealand) Limited
Manufacturers:
Cenexi-Laboratories Thissen SA, Braine-L’Alleud, Belgium
Oncotec Pharma Produktion GmbH, Rosslau, Germany

Product:
Ribomustin
Active Ingredient:
Bendamustine hydrochloride 100mg equivalent to Bendamustine 90.8mg
Dosage Form:
Powder for infusion
New Zealand Sponsor:
Janssen-Cilag (New Zealand) Limited
Manufacturers:
Cenexi-Laboratories Thissen SA, Braine-L’Alleud, Belgium
Oncotec Pharma Produktion GmbH, Rosslau, Germany

Dated this 8th day of May 2015.

CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2015, No 53





✨ LLM interpretation of page content

🏥 Consent to the Distribution of Metvix and Pegasys RBV

🏥 Health & Social Welfare
8 May 2015
Medicine Approval, Metvix, Pegasys RBV, Pharmacy Retailing, Roche Products
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

🏥 Consent to the Distribution of Ribomustin

🏥 Health & Social Welfare
8 May 2015
Medicine Approval, Ribomustin, Janssen-Cilag, Bendamustine
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health