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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:

Ibuprofen Children 3 months–12 years
Ibuprofen 2%
Oral suspension
Multichem NZ Limited
Meditab Specialities Pvt Limited, Maharashtra, India

Product:
Active Ingredients:



Dosage Form:

New Zealand Sponsor:
Manufacturer:

LaxaCon
Macrogol 3350 13125mg
Potassium chloride 46.6mg
Sodium bicarbonate 178.5mg
Sodium chloride 350.7mg
Powder for oral solution
Actavis New Zealand Limited
Strides Arcolab Limited, Bangalore, India

Product:
Active Ingredients:



Dosage Form:

New Zealand Sponsor:
Manufacturer:

LaxaCon-Half
Macrogol 3350 6562.5mg
Potassium chloride 23.3mg
Sodium bicarbonate 89.25mg
Sodium chloride 175.35mg
Powder for oral solution
Actavis New Zealand Limited
Strides Arcolab Limited, Bangalore, India

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

Spedra
Avanafil 50mg
Tablet
Te Arai Biofarma Limited
Mitsubishi Tanabe Pharma Factory Limited, Osaka, Japan

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

Spedra
Avanafil 100mg
Tablet
Te Arai Biofarma Limited
Mitsubishi Tanabe Pharma Factory Limited, Osaka, Japan

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

Spedra
Avanafil 200mg
Tablet
Te Arai Biofarma Limited
Mitsubishi Tanabe Pharma Factory Limited, Osaka, Japan

Dated this 15th day of January 2015.

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