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 set out in the Schedule hereto:

Schedule

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

Adempas
Riociguat 0.5mg
Film coated tablet
Bayer New Zealand Limited
Bayer Pharma AG, Leverkusen, Germany

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

Adempas
Riociguat 1mg
Film coated tablet
Bayer New Zealand Limited
Bayer Pharma AG, Leverkusen, Germany

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

Adempas
Riociguat 2mg
Film coated tablet
Bayer New Zealand Limited
Bayer Pharma AG, Leverkusen, Germany

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

Adempas
Riociguat 1.5mg
Film coated tablet
Bayer New Zealand Limited
Bayer Pharma AG, Leverkusen, Germany

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

Adempas
Riociguat 2.5mg
Film coated tablet
Bayer New Zealand Limited
Bayer Pharma AG, Leverkusen, Germany

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

Granisetron Kabi
Granisetron hydrochloride 1.12mg/mL equivalent to Granisetron 1mg/mL
Concentrate for injection
Fresenius Kabi New Zealand Limited
Fresenius Kabi Austria GmbH, Graz, Austria
Labesfal Laboratories Almiro SA, Santiago de Besteiros, Portugal

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

Orion Temozolomide
Temozolomide 5mg
Capsule
Orion Laboratories (NZ) Limited
NerPharMa SRL, Milano, Italy
Haupt Pharma Amareg GmbH, Regensburg, Germany

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

Orion Temozolomide
Temozolomide 20mg
Capsule
Orion Laboratories (NZ) Limited
NerPharMa SRL, Milano, Italy
Haupt Pharma Amareg GmbH, Regensburg, Germany

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

Orion Temozolomide
Temozolomide 100mg
Capsule
Orion Laboratories (NZ) Limited
NerPharMa SRL, Milano, Italy
Haupt Pharma Amareg GmbH, Regensburg, Germany

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

Orion Temozolomide
Temozolomide 140mg
Capsule
Orion Laboratories (NZ) Limited
NerPharMa SRL, Milano, Italy
Haupt Pharma Amareg GmbH, Regensburg, Germany

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

Orion Temozolomide
Temozolomide 180mg
Capsule
Orion Laboratories (NZ) Limited
NerPharMa SRL, Milano, Italy
Haupt Pharma Amareg GmbH, Regensburg, Germany

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

Orion Temozolomide
Temozolomide 250mg
Capsule
Orion Laboratories (NZ) Limited
NerPharMa SRL, Milano, Italy
Haupt Pharma Amareg GmbH, Regensburg, Germany

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Tachosil
Fibrinogen 5.5mg/cm²
Thrombin 2IU/cm²
Medicated sponge
Research Associates Limited
Takeda Austria GmbH, Linz, Austria

Dated this 21st day of November 2014.

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