✨ Medicines Notices




NEW ZEALAND GAZETTE, No. 101 β€” 10 NOVEMBER 2016

Product:
Arnuity Ellipta
Active Ingredient:
Fluticasone furoate 200mcg
Dosage Form:
Powder for inhalation
New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited
Manufacturer:
Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Hertfordshire, United Kingdom

Product:
Darunavir Mylan
Active Ingredient:
Darunavir 300mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Mylan New Zealand Limited
Manufacturer:
Mylan Laboratories Limited, Sinnar, India

Product:
Darunavir Mylan
Active Ingredient:
Darunavir 400mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Mylan New Zealand Limited
Manufacturer:
Mylan Laboratories Limited, Sinnar, India

Product:
Darunavir Mylan
Active Ingredient:
Darunavir 600mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Mylan New Zealand Limited
Manufacturer:
Mylan Laboratories Limited, Sinnar, India

Product:
Dipyridamole SR Actavis
Active Ingredient:
Dipyridamole 150mg
Dosage Form:
Modified release capsule
New Zealand Sponsor:
Actavis New Zealand Limited
Manufacturer:
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

Product:
Dipyridamole SR Actavis
Active Ingredient:
Dipyridamole 200mg
Dosage Form:
Modified release capsule
New Zealand Sponsor:
Actavis New Zealand Limited
Manufacturer:
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria

Product:
Epclusa
Active Ingredients:
Sofosbuvir 400mg
Velpatasvir 100mg
Dosage Form:
Tablet
New Zealand Sponsor:
Gilead Sciences (NZ)
Manufacturers:
Gilead Sciences Ireland UC, County Cork, Ireland
Patheon Inc, Mississauga, Canada

Product:
Eptifibatide Mylan
Active Ingredient:
Eptifibatide 0.75mg/mL
Dosage Form:
Solution for infusion
New Zealand Sponsor:
Mylan New Zealand Limited
Manufacturer:
Mylan Laboratories Limited, Bangalore, India

Product:
Eptifibatide Mylan
Active Ingredient:
Eptifibatide 2mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Mylan New Zealand Limited
Manufacturer:
Mylan Laboratories Limited, Bangalore, India

Product:
Genvoya
Active Ingredients:
Cobicistat 150mg
Elvitegravir 150mg
Emtricitabine 200mg
Tenofovir alafenamide 10mg
Dosage Form:
Tablet
New Zealand Sponsor:
Gilead Sciences (NZ)
Manufacturer:
Patheon Inc, Mississauga, Canada

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2016, No 101





✨ LLM interpretation of page content

πŸ₯ Consent to the distribution of new medicines

πŸ₯ Health & Social Welfare
Medicines Act 1981, New Medicines, Arnuity Ellipta, Fluticasone furoate

πŸ₯ Consent to the distribution of new medicines

πŸ₯ Health & Social Welfare
Medicines Act 1981, New Medicines, Darunavir Mylan, Darunavir

πŸ₯ Consent to the distribution of new medicines

πŸ₯ Health & Social Welfare
Medicines Act 1981, New Medicines, Dipyridamole SR Actavis, Dipyridamole

πŸ₯ Consent to the distribution of new medicines

πŸ₯ Health & Social Welfare
Medicines Act 1981, New Medicines, Epclusa, Sofosbuvir, Velpatasvir

πŸ₯ Consent to the distribution of new medicines

πŸ₯ Health & Social Welfare
Medicines Act 1981, New Medicines, Eptifibatide Mylan, Eptifibatide

πŸ₯ Consent to the distribution of new medicines

πŸ₯ Health & Social Welfare
Medicines Act 1981, New Medicines, Genvoya, Cobicistat, Elvitegravir, Emtricitabine, Tenofovir alafenamide