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:

Bortezomib - Dr. Reddy’s

Active Ingredient:

Bortezomib 3.5mg

Dosage Form:

Powder for injection

New Zealand Sponsor:

Dr Reddy’s New Zealand Limited

Manufacturer:

Dr Reddy’s Laboratories Limited, Visakhapatnam, Indi

 

 

Product:

Cetirizine Hayfever & Allergy Relief

Active Ingredient:

Cetirizine hydrochloride 10mg

Dosage Form:

Film coated tablet

New Zealand Sponsor:

Medreich New Zealand Limited

Manufacturer:

Medreich Limited, Bangalore, India

 

 

Product:

Cinacalcet Devatis 30mg Film-coated Tablet

Active Ingredient:

Cinacalcet hydrochloride 33.06mg equivalent to cinacalcet 30mg

Dosage Form:

Film coated tablet

New Zealand Sponsor:

Devatis Limited

Manufacturer:

Deva Holding AS, Tekirdag, Turkey

 

 

Product:

Cinacalcet Devatis 60mg Film-coated Tablet

Active Ingredient:

Cinacalcet hydrochloride 66.12mg equivalent to cinacalcet 60mg

Dosage Form:

Film coated tablet

New Zealand Sponsor:

Devatis Limited

Manufacturer:

Deva Holding AS, Tekirdag, Turkey

 

 

Product:

Cinacalcet Devatis 90mg Film-coated Tablet

Active Ingredient:

Cinacalcet hydrochloride 99.18mg equivalent to cinacalcet 90mg

Dosage Form:

Film coated tablet

New Zealand Sponsor:

Devatis Limited

Manufacturer:

Deva Holding AS, Tekirdag, Turkey

 

 

Product:

Medreich Cetirizine Hayfever & Allergy Relief

Active Ingredient:

Cetirizine hydrochloride 10mg

Dosage Form:

Film coated tablet

New Zealand Sponsor:

Medreich New Zealand Limited

Manufacturer:

Medreich Limited, Bangalore, India

 

 

Product:

Melatonin

Active Ingredient:

Melatonin 2mg

Dosage Form:

Modified release tablet

New Zealand Sponsor:

Generic Partners (NZ) Limited

Manufacturer:

Oman Pharmaceutical Products Company LLC, Salalah, Oman

 

 

Product:

Sudafed Triple Benefit Nasal Spray

Active Ingredient:

Xylometazoline hydrochloride 1mg/mL

Dosage Form:

Nasal spray solution

New Zealand Sponsor:

Johnson & Johnson (New Zealand) Limited

Manufacturer:

Famar Health Care Services Madrid SAU, Madrid, Spain

Dated this 26th day of August 2019.

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