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:

Apo-Fingolimod
Fingolimod hydrochloride 0.56mg equivalent to fingolimod 0.50mg
Capsule
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

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

Ceftazidime Kabi
Ceftazidime pentahydrate 1.1648g equivalent to ceftazidime 1g
Powder for injection
Fresenius Kabi New Zealand Limited
Fresenius Kabi iPSUM S.r.l, Rovigo, Italy
Labesfal Laboratories Almiro SA, Santiago de Besteiros, Portugal

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

Ceftazidime Kabi
Ceftazidime pentahydrate 2.3296g equivalent to ceftazidime 2g
Powder for injection
Fresenius Kabi New Zealand Limited
Fresenius Kabi iPSUM S.r.l, Rovigo, Italy
Labesfal Laboratories Almiro SA, Santiago de Besteiros, Portugal

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

Repatha
Evolocumab 140mg/mL
Solution for injection
Amgen New Zealand Limited
Amgen Manufacturing Limited, Juncos, Puerto Rico

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

Repatha (SureClick)
Evolocumab 140mg/mL
Solution for injection
Amgen New Zealand Limited
Amgen Manufacturing Limited, Juncos, Puerto Rico

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

Tacrolimus Sandoz
Tacrolimus monohydrate 0.767mg equivalent to tacrolimus 0.75mg
Capsule
Novartis New Zealand Limited
Sandoz Private Limited, Navi Mumbai, India

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

Tacrolimus Sandoz
Tacrolimus monohydrate 2.044mg equivalent to tacrolimus 2mg
Capsule
Novartis New Zealand Limited
Sandoz Private Limited, Navi Mumbai, India

Dated this 7th day of June 2019.

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