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-Ezetimibe
Ezetimibe 10mg
Tablet
Apotex NZ Limited
Intas Pharmaceuticals Limited, Sanand, India

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

Apo-Lacosamide
Lacosamide 50mg
Film coated tablet
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

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

Apo-Lacosamide
Lacosamide 100mg
Film coated tablet
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

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

Apo-Lacosamide
Lacosamide 150mg
Film coated tablet
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

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

Apo-Lacosamide
Lacosamide 200mg
Film coated tablet
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

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

Brufen One
Ibuprofen 400mg
Film coated tablet
Mylan New Zealand Limited
Famar SA, Attiki, Greece

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

Omeprazole IV
Omeprazole sodium 42.6mg equivalent to omeprazole 40mg
Powder for infusion
REX Medical Limited
Cipla Limited, Salcette, India

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

Sapropterin Dipharma
Sapropterin dihydrochloride 100mg equivalent to sapropterin 76.8mg
Soluble tablet
Te Arai BioFarma Limited
Rubicon Research Pvt. Limited, Anand Nagar, India

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

Signifor LAR
Pasireotide embonate 27.42mg equivalent to pasireotide 20mg
Powder for injection with diluent
Novartis New Zealand Limited
Novartis Pharma AG, Basel, Switzerland

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

Signifor LAR
Pasireotide embonate 54.84mg equivalent to pasireotide 40mg
Powder for injection with diluent
Novartis New Zealand Limited
Novartis Pharma AG, Basel, Switzerland

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

Signifor LAR
Pasireotide embonate 82.26mg equivalent to pasireotide 60mg
Powder for injection with diluent
Novartis New Zealand Limited
Novartis Pharma AG, Basel, Switzerland


Dated this 24th day of May 2018.

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