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:

Apo-Adefovir
Adefovir dipivoxil 10mg
Tablet
Apotex NZ Limited
Apotex Inc, Toronto, Canada

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

APO-Pregabalin
Pregabalin 25mg
Capsule
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

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

APO-Pregabalin
Pregabalin 50mg
Capsule
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

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

APO-Pregabalin
Pregabalin 75mg
Capsule
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

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

APO-Pregabalin
Pregabalin 100mg
Capsule
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

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

APO-Pregabalin
Pregabalin 150mg
Capsule
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

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

APO-Pregabalin
Pregabalin 200mg
Capsule
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

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

APO-Pregabalin
Pregabalin 225mg
Capsule
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

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

APO-Pregabalin
Pregabalin 300mg
Capsule
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Canesten Extra
Clotrimazole 10mg/g
Hydrocortisone acetate 11.2mg/g equivalent to 10mg/g hydrocortisone
Topical cream
Bayer New Zealand Limited
Kern Pharma SL, Terrassa, Spain

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

Ceftriaxone
Ceftriaxone sodium 2.386g equivalent to Ceftriaxone 2g
Powder for infusion
Deva Holdings NZ Limited
Deva Holding AS, Kapakli, Turkey

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

Chloramphenicol multichem
Chloramphenicol 1%w/w
Eye ointment
Multichem NZ Limited
Tubilux Pharma SpA, Rome, Italy

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

DP-Travoprost
Travoprost 40mcg/mL
Eye drops, solution
Douglas Pharmaceuticals Limited
S.C. Rompharm Company S.R.L, Otopeni, Romania

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

Invega Trinza
Paliperidone palmitate 312mg/mL equivalent to palperidone 175mg/dose
Suspension for injection
Janssen-Cilag (New Zealand) Limited
Janssen Pharmaceutica NV, Beerse, Belgium

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

Invega Trinza
Paliperidone palmitate 312mg/mL equivalent to palperidone 263mg/dose
Suspension for injection
Janssen-Cilag (New Zealand) Limited
Janssen Pharmaceutica NV, Beerse, Belgium

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

Invega Trinza
Paliperidone palmitate 312mg/mL equivalent to palperidone 350mg/dose
Suspension for injection
Janssen-Cilag (New Zealand) Limited
Janssen Pharmaceutica NV, Beerse, Belgium

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

Invega Trinza
Paliperidone palmitate 312mg/mL equivalent to palperidone 525mg/dose
Suspension for injection
Janssen-Cilag (New Zealand) Limited
Janssen Pharmaceutica NV, Beerse, Belgium

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

Nausicalm (Restricted)
Cyclizine hydrochloride 50mg
Tablet
AFT Pharmaceuticals Limited
Sigma Laboratories Limited, Mapusa, India

Dated this 5th day of August 2016.

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