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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:

Dexmedetomidine Mylan
Dexmedetomidine hydrochloride 0.118mg/mL
equivalent to dexmedetomidine 0.100mg/mL
Concentrate for infusion
Mylan New Zealand Limited
Mylan Teoranta Limited, Inverin, Ireland

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

Gastro-Stop (General sale)
Loperamide hydrochloride 2mg
Capsule
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Sharon Bio-Medicine Limited, Dehradun, India

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

Gastro-Stop (Pharmacy only)
Loperamide hydrochloride 2mg
Capsule
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Sharon Bio-Medicine Limited, Dehradun, India

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Latanoprost/Timolol Sandoz 50/5
Latanoprost 0.05mg/mL
Timolol maleate 6.83mg/mL equivalent to timolol 5mg/mL
Eye drops, solution
Novartis New Zealand Limited
Aeropharm GmbH, Rudolstadt, Germany

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

Tranexamic Acid Juno (500mg/5mL)
Tranexamic acid 100mg/mL
Solution for injection
Juno Pharmaceuticals NZ Limited
Gland Pharma Limited, Hyderabad, India

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

Tranexamic Acid Juno (1000mg/10mL)
Tranexamic acid 100mg/mL
Solution for injection
Juno Pharmaceuticals NZ Limited
Gland Pharma Limited, Hyderabad, India

Dated this 15th day of January 2018.

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