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:
|
Gazyva
Obinutuzumab 1000mg
Concentrate for infusion
Roche Products (NZ) Limited
Roche Diagnostics GmbH, Mannheim, Germany
|
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
|
Lipiodol Ultra Fluid
Iodised oil 38%w/w
Solution for injection
Obex Medical Limited
Guerbet, Aulnay Sous Bois, France
Delpharm Tours, Chambray Les Tours, France
|
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
|
One Alpha
Alfacalcidol 1mcg
Liquid filled capsule
LEO Pharma Limited
Leo Pharma A/S, Ballerup, Denmark
Catalent France Beinheim SA, Beinheim, France
Swiss Caps AG, Kirchberg, Switzerland
|
|
Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
|
Simdax
Levosimendan 2.5mg/mL
Concentrate for infusion
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Fermion Oy, Espoo, Finland
|
Dated this 15th day of February 2018.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013)
Gazette.govt.nz