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:

Entecavir
Entecavir monohydrate 0.532mg equivalent to entecavir 0.5mg
Film coated tablet
REX Medical Limited
Cipla Limited, Pithampur, India

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

Entecavir
Entecavir monohydrate 1.064mg equivalent to entecavir 1mg
Film coated tablet
REX Medical Limited
Cipla Limited, Pithampur, India

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

Kisqali
Ribociclib succinate 254.4mg equivalent to ribociclib 200mg
Film coated tablet
Novartis New Zealand Limited
Novartis Singapore Pharmaceutical Manufacturing Pte Limited, Singapore

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

Mucinex Sinus 12 Hour Nasal Spray
Oxymetazoline hydrochloride 0.5mg/mL
Nasal spray solution
Reckitt Benckiser (New Zealand) Limited
PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Paracare Paracetamol + Ibuprofen
Ibuprofen 200mg
Paracetamol 500mg
Film coated tablet
PSM Healthcare Limited trading as API Consumer Brands
Medreich Limited, Bangalore, India

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

Rivastigmine Patch BNM 5
Rivastigmine 6.9mg
Transdermal patch
Boucher & Muir (New Zealand) Limited t/a BNM Group
Luye Pharma AG, Miesbach, Germany

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

Rivastigmine Patch BNM 10
Rivastigmine 13.8mg
Transdermal patch
Boucher & Muir (New Zealand) Limited t/a BNM Group
Luye Pharma AG, Miesbach, Germany

Dated this 31st day of May 2019.

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