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: Aerius for Children
Active Ingredient: Desloratadine 2.5mg
Dosage Form: Orodispersible tablet
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: CIMA Labs Inc, Minnesota, United States of America
Product: Cefuroxime-AFT
Active Ingredient: Cefuroxime sodium 275mg equivalent to 250mg cefuroxime
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Medochemie Limited, Limassol, Cyprus
Product: Cefuroxime-AFT
Active Ingredient: Cefuroxime sodium 826mg equivalent to 750mg cefuroxime
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Medochemie Limited, Limassol, Cyprus
Product: Cefuroxime-AFT
Active Ingredient: Cefuroxime sodium 1652mg equivalent to 1500mg cefuroxime
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Medochemie Limited, Limassol, Cyprus
Product: Cipflox
Active Ingredient: Ciprofloxacin 2mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Maco Productions SAS, Mouvaux, France
Product: Loperamide Relief
Active Ingredient: Loperamide hydrochloride 2mg
Dosage Form: Capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Adcock Ingram Limited - A Medreich Group Company, Bangalore, India
Product: Nevirapine Alphapharm
Active Ingredient: Nevirapine 200mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India
Product: Noraped
Active Ingredient: Noradrenaline acid tartrate monohydrate 8mg
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Haupt Pharma Livron, Livron sur Drome, France
Product: Onglyza
Active Ingredient: Saxagliptin 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: Bristol-Myers Squibb Company, Indiana, United States of America
Product: Pravastatin
Active Ingredient: Pravastatin sodium 10mg
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Maharashtra, India
Product: Pravastatin
Active Ingredient: Pravastatin sodium 20mg
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Maharashtra, India
Product: Pravastatin
Active Ingredient: Pravastatin sodium 40mg
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Maharashtra, India
Product: Rizamelt
Active Ingredient: Rizatriptan benzoate 7.265mg equivalent to rizatriptan 5mg
Dosage Form: Orodispersible tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India
Product: Rizamelt
Active Ingredient: Rizatriptan benzoate 14.53mg equivalent to rizatriptan 10mg
Dosage Form: Orodispersible tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India
Product: Tobra-Day
Active Ingredient: Tobramycin sulfate 0.152g/mL equivalent to 0.100 g/mL tobramycin base
Dosage Form: Solution for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Phebra Pty Limited, Lane Cove, Australia
Product: Voltaren Osteo
Active Ingredient: Diclofenac sodium 25mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Novartis Farma SpA, Torre Annunziata, Italy
Novartis Saglik, Istanbul, Turkey
Product: ZAP Topical Anesthetic Gel (Cool Mint)
Active Ingredients: Benzocaine 18%w/w
Tetracaine hydrochloride 2%w/w
Dosage Form: Oral topical gel
New Zealand Sponsor: Healthcare Essentials Limited
Manufacturer: Germiphene Corporation, Ontario, Canada
Dated this 17th day of October 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).