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: Cefazolin-AFT
Active Ingredient: Cefazolin sodium 540mg equivalent to 500mg cefazolin
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Medochemie Limited, Limassol, Cyprus
Product: Cefazolin-AFT
Active Ingredient: Cefazolin sodium 1.08g equivalent to 1g cefazolin
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Medochemie Limited, Limassol, Cyprus
Product: Cerezyme
Active Ingredient: Imiglucerase-rch 400U
Dosage Form: Powder for infusion
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturers: Genzyme Ireland Limited, Waterford, Ireland
Bionique Testing Laboratories, Saranac Lake, United States of America
BioReliance Testing and Development, Incorporated, Rockville, United States of America
Product: Ibuprofen Liquid Capsules
Active Ingredient: Ibuprofen 200mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Geltec Private Limited, Bangalore, India
Product: Ismo 40 Retard
Active Ingredient: Isosorbide mononitrate 40mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Kern Pharma SL, Barcelona, Spain
Product: Naltraccord
Active Ingredient: Naltrexone hydrochloride 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Ahmedabad, India
Product: Resolve Nappy Rash
Active Ingredients: Miconazole 0.25%w/w
Zinc oxide 15%w/w
Dosage Form: Topical ointment
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ego Pharmaceuticals Pty Limited, Braeside, Australia
Product: Ropivacaine-AFT
Active Ingredient: Ropivacaine 1.765mg/mL equivalent to ropivacaine hydrochloride 1.994mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturers: Demo SA Pharmaceutical Industry, Athens, Greece
Pharmathen SA, Pallini, Greece
Product: Ropivacaine-AFT
Active Ingredient: Ropivacaine 6.62mg/mL equivalent to ropivacaine hydrochloride 7.479mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturers: Demo SA Pharmaceutical Industry, Athens, Greece
Pharmathen SA, Pallini, Greece
Product: Ropivacaine-AFT
Active Ingredient: Ropivacaine 8.826mg/mL equivalent to ropivacaine hydrochloride 9.971mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturers: Demo SA Pharmaceutical Industry, Athens, Greece
Pharmathen SA, Pallini, Greece
Product: Silvasta
Active Ingredient: Sildenafil citrate 35.12mg equivalent to 25mg sildenafil
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturers: Actavis hf., Hafnarfjordur, Iceland
Actavis Limited, Zejtun, Malta
Product: Silvasta
Active Ingredient: Sildenafil citrate 70.24mg equivalent to 50mg sildenafil
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturers: Actavis hf., Hafnarfjordur, Iceland
Actavis Limited, Zejtun, Malta
Product: Silvasta
Active Ingredient: Sildenafil citrate 140.48mg equivalent to 100mg sildenafil
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturers: Actavis hf., Hafnarfjordur, Iceland
Actavis Limited, Zejtun, Malta
Dated this 26th day of November 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).