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: Cilatil
Active Ingredient: Tadalafil 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra, India
Product: Cilatil
Active Ingredient: Tadalafil 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra, India
Product: Cilatil
Active Ingredient: Tadalafil 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra, India
Product: Cilatil
Active Ingredient: Tadalafil 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra, India
Product: Cold & Flu Relief + Decongestant Night
Active Ingredients: Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Maharashtra, India
Product: Diafix
Active Ingredient: Loperamide hydrochloride 2mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Drug Houses of Australia Private Limited, Singapore
Product: Ondansetron Kabi
Active Ingredient: Ondansetron hydrochloride dihydrate 2.5mg/mL equivalent to Ondansetron 2mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturer: Labesfal Laboratories Almiro SA, Santiago de Besteiros, Portugal
Product: Priligy
Active Ingredient: Dapoxetine hydrochloride 33.6mg equivalent to Dapoxetine 30mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Te Arai Biofarma Limited
Manufacturers: Janssen Ortho LLC, Gurabo, Puerto Rico
Menarini - Von Heyden GmbH, Dresden, Germany
Product: Priligy
Active Ingredient: Dapoxetine hydrochloride 67.2mg equivalent to Dapoxetine 60mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Te Arai Biofarma Limited
Manufacturers: Janssen Ortho LLC, Gurabo, Puerto Rico
Menarini - Von Heyden GmbH, Dresden, Germany
Product: Stomach Soothe
Active Ingredient: Hyoscine butylbromide 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Drug Houses of Australia Private Limited, Singapore
Dated this 22nd day of May 2014.
SUSAN MARTINDALE, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister
of Health on 11 September 2013).