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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 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

Product: Brintellix
Active Ingredient: Vortioxetine hydrobromide 6.355mg equivalent to vortioxetine 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: H Lundbeck A/S, Valby, Denmark
   
Product: Brintellix
Active Ingredient: Vortioxetine hydrobromide 12.71mg equivalent to vortioxetine 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: H Lundbeck A/S, Valby, Denmark
   
Product: Brintellix
Active Ingredient: Vortioxetine hydrobromide 19.065mg equivalent to vortioxetine 15mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: H Lundbeck A/S, Valby, Denmark
   
Product: Brintellix
Active Ingredient: Vortioxetine hydrobromide 25.42mg equivalent to vortioxetine 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: H Lundbeck A/S, Valby, Denmark
   
Product: Caelyx
Active Ingredient: Doxorubicin hydrochloride 2mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturers:

TTY Biopharm Co Limited, Taiwan, China

GlaxoSmithKline Manufacturing SpA, Parma, Italy

   
Product: Forxiga
Active Ingredient: Dapagliflozin propanediol monohydrate 12.3mg equivalent to dapaglifozin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturers:

Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico

AstraZeneca Pharmaceuticals LP, Indiana, United States of America

   
Product: Ipol
Active Ingredients: Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Dosage Form: Suspension for injection
New Zealand Sponsor: Sanofi-Aventis New Zealand Limited
Manufacturers:

Sanofi Pasteur SA, Marcy L’Etoile, France

Sanofi Pasteur SA, Val-De-Reuil, France

Sanofi Winthrop Industrie, Le Trait, France

   
Product: Sirturo
Active Ingredient: Bedaquiline fumarate 120.89mg equivalent to bedaquiline 100mg
Dosage Form: Tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Recipharm Pharmaservices Private Limited, Nelamangala, India


Dated this 26th day of February 2021.

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