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:
Manufacturers:

Entresto 24/26
Sacubitril/valsartan 50mg equivalent to 24.3mg sacubitril and 25.7mg valsartan
Film coated tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
Novartis Singapore Pharmaceutical Manufacturing Pte Limited, Singapore

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

Entresto 49/51
Sacubitril/valsartan 100mg equivalent to 48.6mg sacubitril and 51.4mg valsartan
Film coated tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
Novartis Singapore Pharmaceutical Manufacturing Pte Limited, Singapore

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

Entresto 97/103
Sacubitril/valsartan 200mg equivalent to 97.2mg sacubitril and 102.8mg valsartan
Film coated tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland
Novartis Singapore Pharmaceutical Manufacturing Pte Limited, Singapore

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

Escitalopram
Escitalopram oxalate 6.387mg equivalent to Escitalopram 5mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Hetero Drugs Limited, Jadcherla Mandal, India

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

Escitalopram
Escitalopram oxalate 12.775mg equivalent to Escitalopram 10mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Hetero Drugs Limited, Jadcherla Mandal, India

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

Escitalopram
Escitalopram oxalate 19.162mg equivalent to Escitalopram 15mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Hetero Drugs Limited, Jadcherla Mandal, India

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

Escitalopram
Escitalopram oxalate 25.55mg equivalent to Escitalopram 20mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Hetero Drugs Limited, Jadcherla Mandal, India

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

Levetiracetam
Levetiracetam 250mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Hetero Labs Limited, Hyderabad, India

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

Levetiracetam
Levetiracetam 500mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Hetero Labs Limited, Hyderabad, India

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

Levetiracetam
Levetiracetam 750mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Hetero Labs Limited, Hyderabad, India

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

Levetiracetam
Levetiracetam 1000mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Hetero Labs Limited, Hyderabad, India

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

Otezla
Apremilast 30mg
Film coated tablet
Celgene Limited
Celgene International Sarl, Boudry, Switzerland
Patheon Inc, Whitby Operations, Whitby, Canada
Patheon Inc, Toronto Region Operations (TRO), Mississauga, Canada

Product:
Component 1:
Active Ingredient:
Dosage Form:
Component 2:
Active Ingredient:
Dosage Form:
Component 3:
Active Ingredient:
Dosage Form:

New Zealand Sponsor:
Manufacturers:

Otezla

Apremilast 10mg
Film coated tablet

Apremilast 20mg
Film coated tablet

Apremilast 30mg
Film coated tablet
Celgene Limited
Celgene International Sarl, Boudry, Switzerland
Patheon Inc, Whitby Operations, Whitby, Canada
Patheon Inc, Toronto Region Operations (TRO), Mississauga, Canada

Dated this 27th day of October 2016.

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