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:

Bimatoprost Multichem
Bimatoprost 0.3mg/mL
Eye drops, solution
Multichem NZ Limited
S.C. Rompharm Company S.R.L, Otopeni, Romania

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

Bisolvon Dry Pastilles
Dextromethorphan hydrobromide monohydrate 10.5mg
Pastille
Boehringer Ingelheim (NZ) Limited
Bolder Arzneimittel GmbH & Co KG, Rhine-Westphalia, Germany

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

Buspirone
Buspirone hydrochloride 5mg
Tablet
Max Health Limited
Orion Corporation, Orion Pharma, Turku, Finland

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

Buspirone
Buspirone hydrochloride 10mg
Tablet
Max Health Limited
Orion Corporation, Orion Pharma, Turku, Finland

Product:
Day Tablet

Active Ingredients:

Night Tablet
Active Ingredients:


Dosage Form:
Lozenge

Active Ingredients:

Dosage Form:
New Zealand Sponsor:

Manufacturers:

Ethics Cold & Flu Combo (Combination Product)

Paracetamol 500mg
Phenylephrine hydrochloride 5mg

Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Film coated tablet

Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Lozenge
Multichem NZ Limited
Cipla Limited, District Raigad, India
Cipla Limited, District Solan, India

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

Praxbind
Idarucizumab 50mg/mL
Solution for injection
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany

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

Vit.D3
Colecalciferol 1.25mg equivalent to 50,000IU
Soft gelatin capsule
Multichem NZ Limited
Geltec Private Limited, Bangalore, India

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Xigduo XR
Dapagliflozin propanediol monohydrate 12.3mg equivalent to Dapagliflozin 10mg
Metformin hydrochloride 500mg
Modified release tablet
AstraZeneca Limited
Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Xigduo XR
Dapagliflozin propanediol monohydrate 12.3mg equivalent to Dapaglifozin 10mg
Metformin hydrochloride 1000mg
Modified release tablet
AstraZeneca Limited
Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Xigduo XR
Dapagliflozin propanediol monohydrate 6.15mg equivalent to Dapaglifozin 5mg
Metformin hydrochloride 1000mg
Modified release tablet
AstraZeneca Limited
Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico

Dated this 4th day of December 2015.

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