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:

Dexiclo
Ciclosporin 100mg
Soft gelatin capsule
Douglas Pharmaceuticals Limited
Swiss Caps AG, Kirchberg, Switzerland

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

Dexiclo
Ciclosporin 25mg
Soft gelatin capsule
Douglas Pharmaceuticals Limited
Swiss Caps AG, Kirchberg, Switzerland

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

Dexiclo
Ciclosporin 50mg
Soft gelatin capsule
Douglas Pharmaceuticals Limited
Swiss Caps AG, Kirchberg, Switzerland

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Ganfort PF 0.3/5
Bimatoprost 300mcg/mL
Timolol maleate 5mg/mL
Eye drops, solution
Allergan New Zealand Limited
Allergan Pharmaceuticals Ireland, County Mayo, Ireland

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

Meropenem Actavis
Meropenem trihydrate 570mg equivalent to Meropenem 500mg
Powder for injection
Actavis New Zealand Limited
ACS Dobfar SpA, Milano, Italy

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

Meropenem Actavis
Meropenem trihydrate 1140mg equivalent to Meropenem 1000mg
Powder for injection
Actavis New Zealand Limited
ACS Dobfar SpA, Milano, Italy

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

Osteomol 665
Paracetamol 665mg
Modified release tablet
Pharmbio Pty Limited
Alkem Laboratories Limited, Himachal Predesh, India

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Potassium 40mmol and 0.9% Sodium Chloride
Potassium chloride 29.8g/L
Sodium chloride 9g/L
Solution for infusion
Baxter Healthcare Limited
Baxter Healthcare Pty Limited, Sydney, Australia

Dated this 17th day of October 2014.

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