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: Atenolol-AFT
Active Ingredient: Atenolol 5mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Chanelle Medical Limited, County Galway, Ireland
Product: Fisamox
Active Ingredient: Amoxicillin sodium 531.6mg equivalent to 500mg Amoxicillin
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Agila Specialties Pvt Limited, Karnataka, India
Product: Fisamox
Active Ingredient: Amoxicillin sodium 1063g equivalent to 1000mg Amoxicillin
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Agila Specialties Pvt Limited, Karnataka, India
Product: Laxofast with Senna
Active Ingredients: Docusate sodium 50mg
Sennosides 8.6mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Marksans Pharma Limited, Goa, India
Product: m-Penicillin V
Active Ingredient: Phenoxymethylpenicillin potassium 277.18mg equivalent to Phenoxymethylpenicillin 250mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Micro Labs Limited, Bangalore, India
Product: m-Penicillin V
Active Ingredient: Phenoxymethylpenicillin potassium 27.72mg/mL equivalent to Phenoxymethylpenicillin 25mg/mL
Dosage Form: Powder for oral solution
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Micro Labs Limited, Bangalore, India
Product: m-Penicillin V
Active Ingredient: Phenoxymethylpenicillin potassium 55.44mg/mL equivalent to Phenoxymethylpenicillin 50mg/mL
Dosage Form: Powder for oral solution
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Micro Labs Limited, Bangalore, India
Dated this 20th day of February 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).