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Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

Publication Date
11 Jun 2020

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2020-go2466
Title
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PDF (37 KB)

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

Product: Apo-Ursodeoxycholic Acid
Active Ingredient: Ursodeoxycholic acid 250mg
Dosage Form: Capsule
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Joint Stock Company “Grindeks”, Riga, Latvia
   
Product: INOVELON
Active Ingredient: Rufinamide 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Eisai New Zealand Limited
Manufacturer: Bushu Pharmaceuticals Limited, Saitama-Ken, Japan
   
Product: INOVELON
Active Ingredient: Rufinamide 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Eisai New Zealand Limited
Manufacturer: Bushu Pharmaceuticals Limited, Saitama-Ken, Japan
   
Product: INOVELON
Active Ingredient: Rufinamide 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Eisai New Zealand Limited
Manufacturer: Bushu Pharmaceuticals Limited, Saitama-Ken, Japan
   
Product: Purell Antiseptic Hand Foam
Active Ingredient: Ethanol 63.7255%w/w
Dosage Form: Foam
New Zealand Sponsor: CARSL Consulting
Manufacturer: Pax Australia Pty Limited, Sydney, Australia
   
Product: Purell Antiseptic Hand Gel
Active Ingredient: Ethanol 65.275%w/w
Dosage Form: Topical gel
New Zealand Sponsor: CARSL Consulting
Manufacturer: Pax Australia Pty Limited, Sydney, Australia
   
Product: Rozlytrek
Active Ingredient: Entrectinib 100mg
Dosage Form: Capsule
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Mayne Pharma Inc, North Carolina, United States of America
   
Product: Rozlytrek
Active Ingredient: Entrectinib 200mg
Dosage Form: Capsule
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Mayne Pharma Inc, North Carolina, United States of America
   
Product: Voke Inhaler
Active Ingredient: Nicotine 0.448mg per dose
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: Nicovations New Zealand Limited
Manufacturers: Pharmaserve (North West) Limited, Runcorn, United Kingdom
Bespak Europe Limited, King’s Lynn, United Kingdom


Dated this 8th day of June 2020.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).