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: Arrow - Amoxicillin
Active Ingredient: Amoxicillin trihydrate 30.3mg/mL on reconstitution equivalent to Amoxicillin 25mg/mL
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Milan Laboratories (India) Pvt Limited, Mumbai, India
Product: Arrow - Amoxicillin
Active Ingredient: Amoxicillin trihydrate 60.26mg/mL on reconstitution equivalent to Amoxicillin 50mg/mL
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Milan Laboratories (India) Pvt Limited, Mumbai, India
Product: Fraxiparine
Active Ingredient: Nadroparin calcium 9500anti-Xa IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Wellcome Production, Notre Dame de Bondeville, France
Product: Fraxiparine Forte
Active Ingredient: Nadroparin calcium 19000anti-Xa IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: Glaxo Wellcome Production, Notre Dame de Bondeville, France
Product: MILOXY 125
Active Ingredient: Amoxicillin trihydrate 30.3mg/mL on reconstitution equivalent to Amoxicillin 25mg/mL
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Milan Laboratories (India) Pvt Limited, Mumbai, India
Product: MILOXY 250
Active Ingredient: Amoxicillin trihydrate 60.26mg/mL on reconstitution equivalent to Amoxicillin 50mg/mL
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Milan Laboratories (India) Pvt Limited, Mumbai, India
Dated this 16th day of January 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).