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 Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Dylastine 125/50
Azelastine hydrochloride 1mg/g
Fluticasone propionate 0.365mg/g
Nasal spray suspension
Mylan New Zealand Limited
Cipla Limited, Verna, India
Cipla Limited, Pithampur, India
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Idelvion
Albutrepenonacog alfa 250IU
Powder for injection
CSL Behring (NZ) Limited
CSL Behring GmbH, Marburg, Germany
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Idelvion
Albutrepenonacog alfa 500IU
Powder for injection
CSL Behring (NZ) Limited
CSL Behring GmbH, Marburg, Germany
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|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Idelvion
Albutrepenonacog alfa 1000IU
Powder for injection
CSL Behring (NZ) Limited
CSL Behring GmbH, Marburg, Germany
|
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
|
Idelvion
Albutrepenonacog alfa 2000IU
Powder for injection
CSL Behring (NZ) Limited
CSL Behring GmbH, Marburg, Germany
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Dated this 23rd day of May 2017.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz