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
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Ribomustin
Bendamustine hydrochloride 25mg equivalent to Bendamustine 22.7mg
Powder for infusion
Janssen-Cilag (New Zealand) Limited
Cenexi-Laboratories Thissen SA, Braine-L’Alleud, Belgium
Oncotec Pharma Produktion GmbH, Rosslau, Germany
|
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
|
Ribomustin
Bendamustine hydrochloride 100mg equivalent to Bendamustine 90.8mg
Powder for infusion
Janssen-Cilag (New Zealand) Limited
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 of Health on 11 September 2013).
Gazette.govt.nz