β¨ Consent to Distribution of New Medicines
NEW ZEALAND GAZETTE, No. 1 β 14 JANUARY 2016
Product:
Active Ingredient:
Imatinib mesilate 478mg equivalent to Imatinib free base 400mg
Dosage Form:
Capsule
New Zealand Sponsor:
Douglas Pharmaceuticals Limited
Manufacturer:
Nobilus Ent, Jablonna, Poland
MYTIB
Product:
Active Ingredient:
Rocuronium bromide 10mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Max Health Limited
Manufacturer:
Hameln Pharmaceuticals GmbH, Hameln, Germany
Dated this 8th day of January 2016.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
2016-go237
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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product:
Active Ingredients:
Human Papillomavirus (HPV) 16 L1 Protein 20mcg
Human Papillomavirus (HPV) 18 L1 Protein 20mcg
Dosage Form:
Suspension for injection
New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited
Manufacturers:
GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals SA, Wavre, Belgium
Cervarix
Product:
Active Ingredient:
Ivacaftor 150mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Novotech (New Zealand) Limited
Manufacturer:
Patheon Pharmaceuticals Inc, Ohio, United States of America
Kalydeco
Product:
Active Ingredient:
Nonacog gamma 50IU/mL equivalent to 250IU/vial
Dosage Form:
Powder for injection with diluent
New Zealand Sponsor:
Baxalta New Zealand Limited
Manufacturers:
Baxter Healthcare Corporation, California, United States of America
Hameln Pharmaceuticals GmbH, Hameln, Germany
RIXUBIS
Product:
Active Ingredient:
Nonacog gamma 100IU/mL equivalent to 500IU/vial
Dosage Form:
Powder for injection with diluent
New Zealand Sponsor:
Baxalta New Zealand Limited
Manufacturers:
Baxter Healthcare Corporation, California, United States of America
Hameln Pharmaceuticals GmbH, Hameln, Germany
RIXUBIS
Product:
Active Ingredient:
Nonacog gamma 200IU/mL equivalent to 1000IU/vial
Dosage Form:
Powder for injection with diluent
New Zealand Sponsor:
Baxalta New Zealand Limited
Manufacturers:
Baxter Healthcare Corporation, California, United States of America
Hameln Pharmaceuticals GmbH, Hameln, Germany
RIXUBIS
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π₯
Consent to the Distribution of New Medicines
(continued from previous page)
π₯ Health & Social Welfare8 January 2016
Medicines, Consent, Distribution, Imatinib, Rocuronium, HPV, Ivacaftor, Nonacog gamma
- DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social WelfareMedicines, Consent, Distribution, HPV, Cervarix, Kalydeco, RIXUBIS
NZ Gazette 2016, No 1