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:

BecloClear
Beclometasone dipropionate 500mcg/g equivalent to beclometasone dipropionate 50mcg per spray
Nasal spray solution
AFT Pharmaceuticals Limited
Jewim Pharmaceutical (Shandong) Co., Limited, Shandong Province, China

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

Jakavi
Ruxolitinib phosphate 6.6mg equivalent to ruxolitinib 5mg
Tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland

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

Jakavi
Ruxolitinib phosphate 19.8mg equivalent to ruxolitinib 15mg
Tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland

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

Jakavi
Ruxolitinib phosphate 26.4mg equivalent to ruxolitinib 20mg
Tablet
Novartis New Zealand Limited
Novartis Pharma Stein AG, Stein, Switzerland

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

Montelukast Mylan
Montelukast sodium 10.4mg equivalent to montelukast 10mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Maharashtra State, India

Dated this 27th day of November 2014.

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