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: Concorda
Active Ingredient: Donepezil hydrochloride 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
Product: Concorda
Active Ingredient: Donepezil hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
Product: Donaccord
Active Ingredient: Donepezil hydrochloride 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
Product: Donaccord
Active Ingredient: Donepezil hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
Product: Fluconazole-Claris
Active Ingredient: Fluconazole 2mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Claris Life Sciences Limited, Ahmedabad, India
Product: Fludarabine Actavis 50
Active Ingredient: Fludarabine phosphate 50mg
Dosage Form: Powder for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: SC Sindan-Pharma SrL, Bucharest, Romania
Product: Glivec
Active Ingredient: Imatinib mesilate 59.75mg equivalent to 50mg imatinib
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Glivec
Active Ingredient: Imatinib mesilate 119.5mg equivalent to 100mg imatinib
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Glivec
Active Ingredient: Imatinib mesilate 119.5mg equivalent to imatinib base 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Glivec
Active Ingredient: Imatinib mesilate 478mg equivalent to imatinib base 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Hydrocortisone Cream 1%
Active Ingredient: Hydrocortisone acetate 1%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Raigad, India
Product: Levetiracetam
Active Ingredient: Levetiracetam 250mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Levetiracetam
Active Ingredient: Levetiracetam 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Levetiracetam
Active Ingredient: Levetiracetam 750mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: m-Amoxicillin
Active Ingredient: Amoxicillin trihydrate 287.5mg equivalent to amoxicillin 250mg
Dosage Form: Capsule
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Micro Labs Limited, Kartnataka, India
Product: m-Amoxicillin
Active Ingredient: Amoxicillin trihydrate 575mg equivalent to amoxicillin 500mg
Dosage Form: Capsule
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Micro Labs Limited, Kartnataka, India
Product: Pentasa
Active Ingredient: Mesalazine 1g
Dosage Form: Modified release tablet
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: Pharbil Pharma GmbH, Bielefeld, Germany
Product: Savacol Antiseptic Mouth & Throat Rinse - Alcohol Free
Active Ingredient: Chlorhexidine gluconate 2mg/mL
Dosage Form: Mouthwash
New Zealand Sponsor: Colgate-Palmolive Limited (NZ)
Manufacturer: GABA International AG, Therwil, Switzerland
Dated this 15th day of July 2010.
JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).