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:

Daklinza
Daclatasvir dihydrochloride 33mg equivalent to daclatasvir 30mg
Tablet
Bristol-Myers Squibb (NZ) Limited
AstraZeneca Pharmaceuticals LP, Indiana, United States of America

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

Daklinza
Daclatasvir dihydrochloride 66mg equivalent to daclatasvir 60mg
Tablet
Bristol-Myers Squibb (NZ) Limited
AstraZeneca Pharmaceuticals LP, Indiana, United States of America

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

Escitalopram Tablets
Escitalopram oxalate 6.37mg equivalent to Escitalopram 5mg
Film coated tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Silvassa, India

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

Escitalopram Tablets
Escitalopram oxalate 12.74mg equivalent to Escitalopram 10mg
Film coated tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Silvassa, India

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

Escitalopram Tablets
Escitalopram oxalate 25.47mg equivalent to Escitalopram 20mg
Film coated tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Silvassa, India

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

Fusidate Actavis
Sodium fusidate 2%
Topical ointment
Actavis New Zealand Limited
Encube Ethicals Private Limited, Ponda, India

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

Ipca-Escitalopram Tablets
Escitalopram oxalate 6.37mg equivalent to Escitalopram 5mg
Film coated tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Silvassa, India

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

Ipca-Escitalopram Tablets
Escitalopram oxalate 12.74mg equivalent to Escitalopram 10mg
Film coated tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Silvassa, India

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

Ipca-Escitalopram Tablets
Escitalopram oxalate 25.47mg equivalent to Escitalopram 20mg
Film coated tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Silvassa, India

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

Lemtrada
Alemtuzumab 10mg/mL
Concentrate for infusion
Sanofi-Aventis New Zealand Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Lopinavir/Ritonavir Mylan
Lopinavir 100mg
Ritonavir 25mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Sinnar, India

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Lopinavir/Ritonavir Mylan
Lopinavir 200mg
Ritonavir 50mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Sinnar, India

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

Oxycodone Sandoz
Oxycodone hydrochloride 5mg
Modified release tablet
Novartis New Zealand Limited
Salutas Pharma GmbH, Barleben, Germany

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

Oxycodone Sandoz
Oxycodone hydrochloride 10mg
Modified release tablet
Novartis New Zealand Limited
Salutas Pharma GmbH, Barleben, Germany

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

Oxycodone Sandoz
Oxycodone hydrochloride 20mg
Modified release tablet
Novartis New Zealand Limited
Salutas Pharma GmbH, Barleben, Germany

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

Oxycodone Sandoz
Oxycodone hydrochloride 40mg
Modified release tablet
Novartis New Zealand Limited
Salutas Pharma GmbH, Barleben, Germany

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

Oxycodone Sandoz
Oxycodone hydrochloride 80mg
Modified release tablet
Novartis New Zealand Limited
Salutas Pharma GmbH, Barleben, Germany

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

Sunvepra
Asunaprevir 100mg
Capsule
Bristol-Myers Squibb (NZ) Limited
Catalent Pharma Solutions LLC, Florida, United States of America

Dated this 24th day of June 2016.

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