Notice Type
Departmental
Notice Title

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 set out in the Schedule hereto:
Schedule
Product: Arrow - Efavirenz
Active Ingredient: Efavirenz 600mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Emcure Pharmaceuticals Limited, Pune, India
Product: Aubagio
Active Ingredient: Teriflunomide 14mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Winthrop Industrie, Compiegne, France
Product: Bimopt
Active Ingredient: Bimatoprost 0.3mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Micro Labs Limited, Bangalore, India
Product: Clinpro 5000 (Bubblegum)
Active Ingredient: Sodium fluoride 1.12%
Dosage Form: Toothpaste
New Zealand Sponsor: 3M New Zealand Limited
Manufacturer: Sheffield Pharmaceuticals, Connecticut, United States of America
Product: Clinpro 5000 (Spearmint)
Active Ingredient: Sodium fluoride 1.12%
Dosage Form: Toothpaste
New Zealand Sponsor: 3M New Zealand Limited
Manufacturer: Sheffield Pharmaceuticals, Connecticut, United States of America
Product: Clinpro 5000 (Vanilla Mint)
Active Ingredient: Sodium fluoride 1.12%
Dosage Form: Toothpaste
New Zealand Sponsor: 3M New Zealand Limited
Manufacturer: Sheffield Pharmaceuticals, Connecticut, United States of America
Product: Flucil
Active Ingredient: Flucloxacillin sodium 524mg equivalent to Flucloxacillin 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Agila Specialties Pvt Limited, Bangalore, India
Product: Flucil
Active Ingredient: Flucloxacillin sodium 1048mg equivalent to Flucloxacillin 1000mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Agila Specialties Pvt Limited, Bangalore, India
Product: INADINE PVP-l Non Adherent Dressing
Active Ingredient: Povidone-iodine 10%w/w
Dosage Form: Medicated dressing
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Systagenix Wound Management Limited, North Yorkshire, United Kingdom
Product: Levetiracetam
Active Ingredient: Levetiracetam 1000mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India
Product: Norditropin NordiLet
Active Ingredient: Somatropin 3.3mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Gentofte, Denmark
Product: Norditropin NordiLet
Active Ingredient: Somatropin 6.66mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Gentofte, Denmark
Product: Norditropin NordiLet
Active Ingredient: Somatropin 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Gentofte, Denmark
Product: NovoRapid FlexTouch
Active Ingredient: Insulin aspart 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturers: Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Hillerod, Denmark
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk Production SAS, Chartres, France
Novo Nordisk Pharmaceutical Industries Inc, North Carolina, United States of America
Novo Nordisk Producao Farmaceutica do Brasil Ltda, Minas Gerais, Brazil
Product: Omnitrope
Active Ingredient: Somatropin 3.33mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz GmbH, Tyrol, Austria
Product: Omnitrope
Active Ingredient: Somatropin 6.67mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz GmbH, Tyrol, Austria
Product: Omnitrope
Active Ingredient: Somatropin 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Sandoz GmbH, Tyrol, Austria
Product: Phenercalm
Active Ingredient: Promethazine hydrochloride 1mg/mL
Dosage Form: Elixir
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Drug Houses of Australia Private Limited, Singapore
Dated this 16th day of December 2013.
SARAH READER, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).