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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

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

Ibugesic
Ibuprofen 200mg
Film coated tablet
REX Medical Limited
Cipla Limited, Patalganga, India
Sharon Bio-Medicine Limited, Dehradun, India

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

Ibuprofen (Pams)
Ibuprofen 200mg
Film coated tablet
REX Medical Limited
Cipla Limited, Patalganga, India
Sharon Bio-Medicine Limited, Dehradun, India

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

Ibuprofen (Rex)
Ibuprofen 200mg
Film coated tablet
REX Medical Limited
Cipla Limited, Patalganga, India

Product:
Active Ingredient:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Kuvan
Sapropterin dihydrochloride 100mg
equivalent to sapropterin 77mg
Soluble tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Excella GmbH & Co KG, Feucht, Germany

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

NovoSeven RT
Eptacog alfa (activated) 1mg
Powder for injection with diluent
Novo Nordisk Pharmaceuticals Limited
Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Kalundborg, Denmark

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

NovoSeven RT
Eptacog alfa (activated) 2mg
Powder for injection with diluent
Novo Nordisk Pharmaceuticals Limited
Novo Nordisk A/S, Copenhagen, Denmark
Novo Nordisk A/S, Kalundborg, Denmark

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

NovoSeven RT
Eptacog alfa (activated) 5mg
Powder for injection with diluent
Novo Nordisk Pharmaceuticals Limited
Novo Nordisk A/S, Copenhagen, Denmark

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

NovoSeven RT
Eptacog alfa (activated) 8mg
Powder for injection with diluent
Novo Nordisk Pharmaceuticals Limited
Novo Nordisk A/S, Copenhagen, Denmark

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

Robinul
Glycopyrronium bromide 0.2mg/mL
Solution for injection
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Hameln Pharmaceuticals GmbH, Hameln, Germany
Biologici Italia Laboratoires Srl, Milan, Italy

Product:
Component 1:
Active Ingredients:


Dosage Form:

Component 2:
Active Ingredients:


Dosage Form:
New Zealand Sponsor:

Manufacturers:

Sudafed PE Phenylephrine Sinus + Pain Day & Night Relief

Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Tablet

Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Tablet
Johnson & Johnson (New Zealand) Limited
Janssen-Cilag, Val de Reuil, France
Probiotec Pharma Pty Limited, Melbourne, Australia

Dated this 1st day of February 2019.

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