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:

Agrylin
Anagrelide hydrochloride 0.61mg equivalent to anagrelide 0.5mg
Capsule
Shire New Zealand Limited
Patheon Manufacturing Services LLC, North Carolina, United States of America

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

Apo-Furosemide
Furosemide 20mg
Tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Pithampur, India

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

Apo-Furosemide
Furosemide 40mg
Tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Pithampur, India

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

Hydroxycarbamide
Hydroxycarbamide 500mg
Capsule
Devatis Limited
Deva Holding AS, Tekirdag, Turkey

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

IPCA-Frusemide
Furosemide 20mg
Tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Pithampur, India

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

IPCA-Frusemide
Furosemide 40mg
Tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Pithampur, India

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

Jakavi
Ruxolitinib phosphate 13.2mg equivalent to ruxolitinib 10mg
Tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland

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

Metermine
Phentermine 15mg
Modified release capsule
iNova Pharmaceuticals (New Zealand) Limited
Douglas Manufacturing Limited, Auckland, New Zealand

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

Metermine
Phentermine 30mg
Modified release capsule
iNova Pharmaceuticals (New Zealand) Limited
Douglas Manufacturing Limited, Auckland, New Zealand

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

Methadone BNM
Methadone hydrochloride 5mg
Tablet
Boucher & Muir (New Zealand) Limited t/a BNM Group
Extractum Pharma Limited, Kunfeherto, Hungary

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

Oedemid
Furosemide 20mg
Tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Pithampur, India

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

Oedemid
Furosemide 40mg
Tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Pithampur, India


Dated this 1st day of April 2019.

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