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:

Bisoprolol
Bisoprolol fumarate 1.25mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Ipca Laboratories Limited, Silvassa, India

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

Bisoprolol
Bisoprolol fumarate 2.5mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Ipca Laboratories Limited, Silvassa, India

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

Bisoprolol
Bisoprolol fumarate 3.75mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Ipca Laboratories Limited, Silvassa, India

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

Bisoprolol
Bisoprolol fumarate 5mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Ipca Laboratories Limited, Silvassa, India

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

Bisoprolol
Bisoprolol fumarate 7.5mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Ipca Laboratories Limited, Silvassa, India

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

Bisoprolol
Bisoprolol fumarate 10mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Ipca Laboratories Limited, Silvassa, India

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

Ipca-Bisoprolol
Bisoprolol fumarate 1.25mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Ipca Laboratories Limited, Silvassa, India

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

Ipca-Bisoprolol
Bisoprolol fumarate 2.5mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Ipca Laboratories Limited, Silvassa, India

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

Ipca-Bisoprolol
Bisoprolol fumarate 3.75mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Ipca Laboratories Limited, Silvassa, India

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

Ipca-Bisoprolol
Bisoprolol fumarate 5mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Ipca Laboratories Limited, Silvassa, India

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

Ipca-Bisoprolol
Bisoprolol fumarate 7.5mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Ipca Laboratories Limited, Silvassa, India

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

Ipca-Bisoprolol
Bisoprolol fumarate 10mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Ipca Laboratories Limited, Silvassa, India

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

Mitomycin
Mitomycin 2mg
Powder for injection
Teva Pharma (New Zealand) Limited
Intas Pharmaceuticals Limited, Near Village Matoda, India

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

Mitomycin
Mitomycin 10mg
Powder for injection
Teva Pharma (New Zealand) Limited
Intas Pharmaceuticals Limited, Near Village Matoda, India

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

Mitomycin
Mitomycin 20mg
Powder for injection
Teva Pharma (New Zealand) Limited
Intas Pharmaceuticals Limited, Near Village Matoda, India

Dated this 25th day of March 2019.

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