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: Advate
Active Ingredient: Octocog alfa 250IU
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter AG, Vienna, Austria
Baxter Bioscience AG, Neuchatel, Switzerland
Product: Advate
Active Ingredient: Octocog alfa 500IU
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter AG, Vienna, Austria
Baxter Bioscience AG, Neuchatel, Switzerland
Product: Advate
Active Ingredient: Octocog alfa 1000IU
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter AG, Vienna, Austria
Baxter Bioscience AG, Neuchatel, Switzerland
Product: Advate
Active Ingredient: Octocog alfa 1500IU
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter AG, Vienna, Austria
Baxter Bioscience AG, Neuchatel, Switzerland
Product: Advate
Active Ingredient: Octocog alfa 2000IU
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter AG, Vienna, Austria
Baxter Bioscience AG, Neuchatel, Switzerland
Product: Advate
Active Ingredient: Octocog alfa 3000IU
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter AG, Vienna, Austria
Baxter Bioscience AG, Neuchatel, Switzerland
Product: Emla
Active Ingredients: Lidocaine 2.5%w/w
Prilocaine 2.5%w/w
Dosage Form: Topical cream
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: Recipharm Stockholm AB, Karlskoga, Sweden
Product: Emla Patch
Active Ingredients: Lidocaine 2.5%
Prilocaine 2.5%
Dosage Form: Dermal patch
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: Recipharm Stockholm AB, Karlskoga, Sweden
Product: Exelon Patch 5
Active Ingredient: Rivastigmine 9mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: LTS Lohmann Therapie-Systeme AG, Andernach, Germany
Product: Exelon Patch 10
Active Ingredient: Rivastigmine 18mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: LTS Lohmann Therapie-Systeme AG, Andernach, Germany
Product: Exelon Patch 15
Active Ingredient: Rivastigmine 27mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: LTS Lohmann Therapie-Systeme AG, Andernach, Germany
Product: Exelon Patch 20
Active Ingredient: Rivastigmine 36mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: LTS Lohmann Therapie-Systeme AG, Andernach, Germany
Dated this 31st day of January 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).