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:

Codral Cold & Flu
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Film coated tablet
Johnson & Johnson (New Zealand) Limited
Janssen-Cilag, Val de Reuil, France

Product:
Component 1:

Active Ingredients:

Dosage Form:
Component 2:
Active Ingredients:


Dosage Form:
New Zealand Sponsor:
Manufacturer:

Codral Day & Night Cold & Flu

Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Film coated tablet

Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Film coated tablet
Johnson & Johnson (New Zealand) Limited
Janssen-Cilag, Val de Reuil, France

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

Decongestant 12 Hour Nasal Spray
Oxymetazoline hydrochloride 0.5mg/mL
Nasal spray solution
PSM Healthcare Limited trading as API Consumer Brands
PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Dimetapp Cold & Flu
Paracetamol 300mg
Phenylephrine hydrochloride 5mg

Liquid filled capsule
Pfizer New Zealand Limited
Catalent Australia Pty Limited, Melbourne, Australia

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer/s:

Dimetapp Multi Symptom Cold & Flu
Paracetamol 300mg
Phenylephrine hydrochloride 5mg

Liquid filled capsule
Pfizer New Zealand Limited
Catalent Australia Pty Limited, Melbourne, Australia

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

Esmya
Ulipristal acetate 5mg
Tablet
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Cenexi SAS, Paris, France

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

Paracetamol OptiTab (General sale)
Paracetamol 500mg
Film coated tablet
Generic Partners (NZ) Limited
Gracure Pharmaceuticals Limited, Bhiwadi, India

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

Paracetamol OptiTab (Pharmacy only)
Paracetamol 500mg
Film coated tablet
Generic Partners (NZ) Limited
Gracure Pharmaceuticals Limited, Bhiwadi, India

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

Stomach Soothe
Hyoscine butylbromide 10mg
Film coated tablet
Teva Pharma (New Zealand) Limited
PT Actavis Indonesia, Jakarta, Indonesia

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

Strepfen Intensive
Flurbiprofen 16.2mg/mL equivalent to 8.748mg per dose
Oral spray
Reckitt Benckiser (New Zealand) Limited
Reckitt Benckiser Healthcare Manufacturing (Thailand) Limited, Bangplee, Thailand


Dated this 5th day of December 2017.

ALISON COSSAR, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on the 11th day of September 2013).