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:

Aciclovir Mylan
Aciclovir sodium 314.4mg equivalent to Aciclovir 250mg
Powder for infusion
Mylan New Zealand Limited
Mylan Laboratories Limited, Bangalore, India

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

Aciclovir Mylan
Aciclovir sodium 628.8mg equivalent to Aciclovir 500mg
Powder for infusion
Mylan New Zealand Limited
Mylan Laboratories Limited, Bangalore, India

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

Apo-Atomoxetine
Atomoxetine hydrochloride 11.4mg equivalent to Atomoxetine 10mg
Capsule
Apotex NZ Limited
Apotex Inc, Etobicoke, Canada

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

Apo-Atomoxetine
Atomoxetine hydrochloride 20.5mg equivalent to Atomoxetine 18mg
Capsule
Apotex NZ Limited
Apotex Inc, Etobicoke, Canada

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

Apo-Atomoxetine
Atomoxetine hydrochloride 28.5mg equivalent to Atomoxetine 25mg
Capsule
Apotex NZ Limited
Apotex Inc, Etobicoke, Canada

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

Apo-Atomoxetine
Atomoxetine hydrochloride 45.5mg equivalent to Atomoxetine 40mg
Capsule
Apotex NZ Limited
Apotex Inc, Etobicoke, Canada

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

Apo-Atomoxetine
Atomoxetine hydrochloride 68.3mg equivalent to Atomoxetine 60mg
Capsule
Apotex NZ Limited
Apotex Inc, Etobicoke, Canada

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

Apo-Atomoxetine
Atomoxetine hydrochloride 91.2mg equivalent to Atomoxetine 80mg
Capsule
Apotex NZ Limited
Apotex Inc, Etobicoke, Canada

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

Apo-Atomoxetine
Atomoxetine hydrochloride 114mg equivalent to Atomoxetine 100mg
Capsule
Apotex NZ Limited
Apotex Inc, Etobicoke, Canada

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

Pheburane
Sodium phenylbutyrate 483mg/g
Oral granules
Orpharma NZ Limited
Rottendorf Pharma GmbH, Ennigerloh, Germany

Dated this 24th day of October 2015.

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