Notice Type
Departmental
Notice Title

Consent to the Distribution of a New Medicine

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 Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Abacavir/Lamivudine Mylan
Abacavir sulfate 702.78mg equivalent to abacavir 600mg
Lamivudine 300mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Aurangabad, India

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

Entecavir Sandoz
Entecavir monohydrate 0.532mg equivalent to entecavir 0.5mg
Film coated tablet
Novartis New Zealand Limited
Lek Pharmaceuticals d.d., Ljubljana, Slovenia

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

Entecavir Sandoz
Entecavir monohydrate 1.065mg equivalent to entecavir 1mg
Film coated tablet
Novartis New Zealand Limited
Lek Pharmaceuticals d.d., Ljubljana, Slovenia

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

Fluconazole (Rex)
Fluconazole 50mg
Capsule
REX Medical Limited
Cipla Limited, Pune, India

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

Fluconazole (Rex)
Fluconazole 150mg
Capsule
REX Medical Limited
Cipla Limited, Pune, India

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

Fluconazole (Rex)
Fluconazole 200mg
Capsule
REX Medical Limited
Cipla Limited, Kurkumbh Village, India

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

Ibuprofen Suspension (Pharmacy Health)
Ibuprofen 20mg/mL
Oral suspension
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:

Imatinib (Rex)
Imatinib mesilate 119.5mg equivalent to imatinib 100mg
Capsule
REX Medical Limited
Cipla Limited, Verna, India

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

Imatinib (Rex)
Imatinib mesilate 478mg equivalent to imatinib 400mg
Capsule
REX Medical Limited
Cipla Limited, Verna, India

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

Pravastatin Sandoz
Pravastatin sodium 20mg
Tablet
Novartis New Zealand Limited
Lek Pharmaceuticals d.d., Ljubljana, Slovenia

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

Pravastatin Sandoz
Pravastatin sodium 40mg
Tablet
Novartis New Zealand Limited
Lek Pharmaceuticals d.d., Ljubljana, Slovenia

Dated this 11th 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).