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:

Alprolix
Eftrenonacog alfa 250IU
Powder with diluent
Biogen Idec NZ Limited
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

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

Alprolix
Eftrenonacog alfa 500IU
Powder with diluent
Biogen Idec NZ Limited
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

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

Alprolix
Eftrenonacog alfa 1000IU
Powder with diluent
Biogen Idec NZ Limited
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

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

Alprolix
Eftrenonacog alfa 2000IU
Powder with diluent
Biogen Idec NZ Limited
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

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

Alprolix
Eftrenonacog alfa 3000IU
Powder with diluent
Biogen Idec NZ Limited
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany

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

Apo-Metoprolol
Metoprolol tartrate 50mg
Film coated tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Dadra and Nagar Haveli, India

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

Apo-Metoprolol
Metoprolol tartrate 100mg
Film coated tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Dadra and Nagar Haveli, India

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

Etocar
Metoprolol tartrate 50mg
Film coated tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Dadra and Nagar Haveli, India

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

Etocar
Metoprolol tartrate 100mg
Film coated tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Dadra and Nagar Haveli, India

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

IPCA-Metoprolol
Metoprolol tartrate 50mg
Film coated tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Dadra and Nagar Haveli, India

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

IPCA-Metoprolol
Metoprolol tartrate 100mg
Film coated tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Dadra and Nagar Haveli, India

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

Ketamine-Claris
Ketamine hydrochloride 115.34mg/mL equivalent to Ketamine 100mg/mL
Solution for injection
AFT Pharmaceuticals Limited
Claris Injectables Limited, Gujarat, India

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

Keytruda
Pembrolizumab 50mg
Powder for infusion
Merck Sharp & Dohme (New Zealand) Limited
Schering-Plough Company, County Cork, Ireland

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

OLYSIO
Simeprevir sodium 154.4mg equivalent to Simeprevir 150mg
Capsule
Janssen-Cilag (New Zealand) Limited
Janssen-Cilag SpA, Latina, Italy

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

Oxycodone Controlled Release Tablets
Oxycodone hydrochloride 5mg
Modified release tablet
Boucher & Muir (New Zealand) Limited t/a BNM Group
Acino Pharma AG, Liesberg, Switzerland

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

Oxycodone Controlled Release Tablets
Oxycodone hydrochloride 10mg
Modified release tablet
Boucher & Muir (New Zealand) Limited t/a BNM Group
Acino Pharma AG, Liesberg, Switzerland

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

Oxycodone Controlled Release Tablets
Oxycodone hydrochloride 15mg
Modified release tablet
Boucher & Muir (New Zealand) Limited t/a BNM Group
Acino Pharma AG, Liesberg, Switzerland

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

Oxycodone Controlled Release Tablets
Oxycodone hydrochloride 20mg
Modified release tablet
Boucher & Muir (New Zealand) Limited t/a BNM Group
Acino Pharma AG, Liesberg, Switzerland

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

Oxycodone Controlled Release Tablets
Oxycodone hydrochloride 30mg
Modified release tablet
Boucher & Muir (New Zealand) Limited t/a BNM Group
Acino Pharma AG, Liesberg, Switzerland

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

Oxycodone Controlled Release Tablets
Oxycodone hydrochloride 40mg
Modified release tablet
Boucher & Muir (New Zealand) Limited t/a BNM Group
Acino Pharma AG, Liesberg, Switzerland

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

Oxycodone Controlled Release Tablets
Oxycodone hydrochloride 60mg
Modified release tablet
Boucher & Muir (New Zealand) Limited t/a BNM Group
Acino Pharma AG, Liesberg, Switzerland

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

Oxycodone Controlled Release Tablets
Oxycodone hydrochloride 80mg
Modified release tablet
Boucher & Muir (New Zealand) Limited t/a BNM Group
Acino Pharma AG, Liesberg, Switzerland

Dated this 27th day of August 2015.

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