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 Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Apo-Alendronate Plus D3
Alendronate sodium trihydrate 91.37mg equivalent to alendronate 70mg
Colecalciferol 70mcg
Tablet
Apotex NZ Limited
Apotex Inc, Weston, Canada

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

Apo-Alendronate Plus D3
Alendronate sodium trihydrate 91.37mg equivalent to alendronate 70mg
Colecalciferol 140mcg
Tablet
Apotex NZ Limited
Apotex Inc, Weston, Canada

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

Dulcolax SP Drops
Sodium picosulfate monohydrate 7.5mg/mL
Oral solution
Sanofi-Aventis New Zealand Limited
Istituto de Angeli SrL, Florence, Italy

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

Freeway Anti-inflammatory Throat spray
Benzydamine hydrochloride 1.5mg/mL
Oral spray
Douglas Pharmaceuticals Limited
Douglas Manufacturing Limited, Auckland, New Zealand

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

Freeway Double Strength Anti-inflammatory Throat spray
Benzydamine hydrochloride 3mg/mL
Oral spray
Douglas Pharmaceuticals Limited
Douglas Manufacturing Limited, Auckland, New Zealand

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

JAQINUS
Tofacitinib citrate 8.078mg equivalent to tofacitinib 5mg
Film coated tablet
Pfizer New Zealand Limited
Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany

Dated this 21st day of August 2017.

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