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:

Baclofen Sintetica
Baclofen 0.05mg/mL
Solution for injection
Max Health Limited
Sintetica SA, Mendrisio, Switzerland

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

Baclofen Sintetica
Baclofen 0.5mg/mL
Solution for infusion
Max Health Limited
Sintetica SA, Mendrisio, Switzerland

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

Baclofen Sintetica
Baclofen 2mg/mL
Solution for infusion
Max Health Limited
Sintetica SA, Mendrisio, Switzerland

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

GenRx-Allopurinol
Allopurinol 100mg
Tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Silvassa, India

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

GenRx-Allopurinol
Allopurinol 300mg
Tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Silvassa, India

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Imodium Advanced (Pharmacy Only)
Loperamide hydrochloride 2mg
Simeticone 125mg
Chewable tablet
Johnson & Johnson (New Zealand) Limited
Probiotec Pharma Pty Limited, Melbourne, Australia

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Imodium Advanced (General Sale)
Loperamide hydrochloride 2mg
Simeticone 125mg
Chewable tablet
Johnson & Johnson (New Zealand) Limited
Probiotec Pharma Pty Limited, Melbourne, Australia

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

Ipca-Allopurinol
Allopurinol 100mg
Tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Silvassa, India

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

Ipca-Allopurinol
Allopurinol 300mg
Tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Silvassa, India

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

Xandane
Allopurinol 100mg
Tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Silvassa, India

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

Xandane
Allopurinol 300mg
Tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Silvassa, India


Dated this 15th day of April 2016.

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