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).