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:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Alprolix
Eftrenonacog alfa 250IU
Powder for infusion
Sanofi-Aventis New Zealand Limited
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Alprolix
Eftrenonacog alfa 500IU
Powder for infusion
Sanofi-Aventis New Zealand Limited
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Alprolix
Eftrenonacog alfa 1000IU
Powder for infusion
Sanofi-Aventis New Zealand Limited
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Alprolix
Eftrenonacog alfa 2000IU
Powder for infusion
Sanofi-Aventis New Zealand Limited
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Alprolix
Eftrenonacog alfa 3000IU
Powder for infusion
Sanofi-Aventis New Zealand Limited
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturers:

Exforge
Amlodipine besilate 6.94mg equivalent to amlodipine 5mg
Valsartan 80mg
Film coated tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farmaceutica SA, Barcelona, Spain

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturers:

Exforge
Amlodipine besilate 13.87mg equivalent to amlodipine 10mg
Valsartan 160mg
Film coated tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farmaceutica SA, Barcelona, Spain

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturers:

Exforge
Amlodipine besilate 6.94mg equivalent to amlodipine 5mg
Valsartan 160mg
Film coated tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farmaceutica SA, Barcelona, Spain

Product:
Active Ingredients:


Dosage Form:
New Zealand Sponsor:
Manufacturers:

Exforge HCT
Amlodipine besilate 13.87mg equivalent to amlodipine 10mg
Hydrochlorothiazide 25mg
Valsartan 320mg
Film coated tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farmaceutica SA, Barcelona, Spain

Product:
Active Ingredients:


Dosage Form:

New Zealand Sponsor:
Manufacturers:

Exforge HCT
Amlodipine besilate 13.87mg equivalent to amlodipine 10mg
Hydrochlorothiazide 25mg
Valsartan 160mg
Film coated tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farmaceutica SA, Barcelona, Spain

Product:
Active Ingredients:


Dosage Form:
New Zealand Sponsor:
Manufacturers:

Exforge HCT
Amlodipine besilate 13.87mg equivalent to amlodipine 10mg
Hydrochlorothiazide 12.5mg
Valsartan 160mg
Film coated tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farmaceutica SA, Barcelona, Spain

Product:
Active Ingredients:


Dosage Form:
New Zealand Sponsor:
Manufacturers:

Exforge HCT
Amlodipine besilate 6.94mg equivalent to amlodipine 5mg
Hydrochlorothiazide 25mg
Valsartan 160mg
Film coated tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farmaceutica SA, Barcelona, Spain

Product:
Active Ingredients:


Dosage Form:
New Zealand Sponsor:
Manufacturers:

Exforge HCT
Amlodipine besilate 6.94mg equivalent to amlodipine 5mg
Hydrochlorothiazide 12.5mg
Valsartan 160mg
Film coated tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farmaceutica SA, Barcelona, Spain

Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Merieux Inactivated Rabies Vaccine (MIRV)
Rabies vaccine, Wistar PM/WI 38-1503-3M 2.5IU
Powder for injection
Sanofi-Aventis New Zealand Limited
Sanofi Pasteur SA, Marcy L’Etoile, France
Sanofi Pasteur SA, Val-De-Reuil, France

Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Typhim Vi vaccine
Salmonella typhi Vi polysaccharide 0.025mg
Solution for injection
Sanofi-Aventis New Zealand Limited
Sanofi Pasteur SA, Marcy L’Etoile, France
Sanofi Winthrop Industrie, Le Trait, France

Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

VIMIZIM
Elosulfase alfa 1mg/mL
Concentrate for injection
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen , Germany

Dated this 25th day of February 2019.

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