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 Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

4% Articadent DENTAL with Adrenaline 1:100,000
Adrenaline acid tartrate 10mcg/mL
Articaine hydrochloride 40mg/mL
Solution for injection
Dentsply (NZ) Limited
Laboratorios INIBSA, Barcelona, Spain

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

Solifenacin
Solifenacin succinate 5mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Jubilant Generics Limited, Bhagwanpur, India

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

Solifenacin
Solifenacin succinate 10mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Jubilant Generics Limited, Bhagwanpur, India

Dated this 21st day of October 2016.

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