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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: Duodopa
Active Ingredients: Carbidopa monohydrate 5mg/mL
Levodopa 20mg/mL
Dosage Form: Intestinal gel
New Zealand Sponsor: AbbVie Limited
Manufacturers: Fresenius Kabi Norge AS, Halden, Norway
AbbVie Inc, Illinois, United States of America
   
Product: Exforge
Active Ingredients: Amlodipine besilate 6.94mg equivalent to amlodipine 5mg
Valsartan 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farmaceutica SA, Barcelona, Spain
   
Product: Exforge
Active Ingredients: Amlodipine besilate 6.94mg equivalent to amlodipine 5mg
Valsartan 160mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farmaceutica SA, Barcelona, Spain
   
Product: Exforge
Active Ingredients: Amlodipine besilate 13.87mg equivalent to amlodipine 10mg
Valsartan 160mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farmaceutica SA, Barcelona, Spain
   
Product: Exforge HCT
Active Ingredients: Amlodipine besilate 6.94mg equivalent to amlodipine 5mg
Hydrochlorothiazide 12.5mg
Valsartan 160mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farmaceutica SA, Barcelona, Spain
   
Product: Exforge HCT
Active Ingredients: Amlodipine besilate 6.94mg equivalent to amlodipine 5mg
Hydrochlorothiazide 25mg
Valsartan 160mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farmaceutica SA, Barcelona, Spain
   
Product: Exforge HCT
Active Ingredients: Amlodipine besilate 13.87mg equivalent to amlodipine 10mg
Hydrochlorothiazide 12.5mg
Valsartan 160mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farmaceutica SA, Barcelona, Spain
   
Product: Exforge HCT
Active Ingredients: Amlodipine besilate 13.87mg equivalent to amlodipine 10mg
Hydrochlorothiazide 25mg
Valsartan 160mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farmaceutica SA, Barcelona, Spain
   
Product: Exforge HCT
Active Ingredients: Amlodipine besilate 13.87mg equivalent to amlodipine 10mg
Hydrochlorothiazide 25mg
Valsartan 320mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farmaceutica SA, Barcelona, Spain
   
Product: Kyprolis
Active Ingredient: Carfilzomib 30mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Amgen New Zealand Limited
Manufacturers: Patheon Manufacturing Services LLC, North Carolina, United States of America
Amgen Technology (Ireland) Unlimited Company, Dublin, Ireland
   
Product: Kyprolis
Active Ingredient: Carfilzomib 60mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Amgen New Zealand Limited
Manufacturers: Patheon Manufacturing Services LLC, North Carolina, United States of America
Baxter Oncology GmbH, Westfalen, Germany
Amgen Technology (Ireland) Unlimited Company, Dublin, Ireland
   
Product: Xgeva
Active Ingredient: Denosumab 120mg
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Limited
Manufacturer: Amgen Manufacturing Limited, Juncos, Puerto Rico


Dated this 10th day of January 2020.

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