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:

Arrow-Dihydrocodeine CR
Dihydrocodeine hydrogen tartrate 60mg
Modified release tablet
Actavis New Zealand Limited
Saneca Pharmaceuticals AS, Hlohovec, Slovakia

Product:
Active Ingredients:


Dosage Form:

New Zealand Sponsor:
Manufacturer:

Congested Cold & Cough
Brompheniramine maleate 0.4mg/mL
Dextromethorphan hydrobromide monohydrate 2mg/mL
Phenylephrine hydrochloride 1mg/mL
Oral solution
PSM Healthcare Limited trading as API Consumer Brands
PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand

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

DP-Capecitabine
Capecitabine 150mg
Film coated tablet
Douglas Pharmaceuticals Limited
Hetero Labs Limited, Andhra Pradesh, India

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

DP-Capecitabine
Capecitabine 500mg
Film coated tablet
Douglas Pharmaceuticals Limited
Hetero Labs Limited, Andhra Pradesh, India

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

Ezetimibe Actavis
Ezetimibe 10mg
Tablet
Actavis New Zealand Limited
Watson Pharma Private Limited, Goa, India

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

Levetiracetam Actavis
Levetiracetam 250mg
Film coated tablet
Actavis New Zealand Limited
Actavis ehf, Hafnarfjordur, Iceland

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

Levetiracetam Actavis
Levetiracetam 500mg
Film coated tablet
Actavis New Zealand Limited
Actavis ehf, Hafnarfjordur, Iceland

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

Levetiracetam Actavis
Levetiracetam 750mg
Film coated tablet
Actavis New Zealand Limited
Actavis ehf, Hafnarfjordur, Iceland

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

Levetiracetam Actavis
Levetiracetam 1000mg
Film coated tablet
Actavis New Zealand Limited
Actavis ehf, Hafnarfjordur, Iceland

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

Ranitidine Relief
Ranitidine hydrochloride 167.5mg equivalent to Ranitidine 150mg
Film coated tablet
Mylan New Zealand Limited
Adcock Ingram Limited – A Medreich Group Company, Bangalore, India
Medreich Limited, Bangalore, India

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

Sylvant
Siltuximab 100mg
Powder for infusion concentrate
Janssen-Cilag (New Zealand) Limited
Cilag AG, Schaffhausen, Switzerland

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

Sylvant
Siltuximab 400mg
Powder for infusion concentrate
Janssen-Cilag (New Zealand) Limited
Cilag AG, Schaffhausen, Switzerland

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

Voltaren Osteo Gel 12 Hourly
Diclofenac diethylamine 2.32% equivalent to diclofenac 2%
Topical gel
Novartis Consumer Health Australasia Pty Limited (New Zealand)
Novartis Consumer Health SA, Nyon, Switzerland

Dated this 26th day of June 2015.

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