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
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Alecensa
Alectinib hydrochloride 161.33mg equivalent to alectinib 150mg
Capsule
Roche Products (NZ) Limited
Excella GmbH & Co KG, Feucht, Germany
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Note: The application received 15 January 2018 is for the dosage and administration and related sections on the draft New Zealand Data Sheet.
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Alecensa
Alectinib hydrochloride 161.33mg equivalent to alectinib 150mg
Capsule
Roche Products (NZ) Limited
Excella GmbH & Co KG, Feucht, Germany
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Note: The application received 16 January 2018 is for the therapeutic indication.
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Venclexta
Venetoclax 10mg
Film coated tablet
AbbVie Limited
AbbVie Ireland NL B.V., Sligo, Ireland
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Venclexta
Venetoclax 50mg
Film coated tablet
AbbVie Limited
AbbVie Ireland NL B.V., Sligo, Ireland
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Venclexta
Venetoclax 100mg
Film coated tablet
AbbVie Limited
AbbVie Ireland NL B.V., Sligo, Ireland
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Product:
Component 1:
Active Ingredient:
Dosage Form:
Component 2:
Active Ingredient:
Dosage Form:
Component 3:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Venclexta
Venetoclax 10mg
Film coated tablet
Venetoclax 50mg
Film coated tablet
Venetoclax 100mg
Film coated tablet
AbbVie Limited
AbbVie Ireland NL B.V., Sligo, Ireland
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Zeffix
Lamivudine 5mg/mL
Oral solution
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline (Canada) Inc, Mississauga, Canada
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Zeffix
Lamivudine 100mg
Film coated tablet
GlaxoSmithKline (NZ) Limited
Glaxo Operations UK Limited t/a Glaxo Welcome Operations, Ware, United Kingdom
GlaxoSmithKline Pharmaceuticals SA, Poznan, Poland
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Dated this 13th day of August 2018.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz