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: A-Amlodipine
Active Ingredient: Amlodipine besilate 6.935mg equivalent to 5mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Silvassa, India
Product: A-Amlodipine
Active Ingredient: Amlodipine besilate 13.88mg equivalent to 10mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Silvassa, India
Product: Amlodipine
Active Ingredient: Amlodipine besilate 13.88mg equivalent to 10mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Silvassa, India
Product: Amlodipine
Active Ingredient: Amlodipine besilate 6.935mg equivalent to 5mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Silvassa, India
Product: Compound Sodium Lactate
Active Ingredients: Calcium chloride dihydrate 0.27g
Potassium chloride 0.4g
Sodium chloride 6g
Sodium lactate 3.17g
Dosage Form: Solution for infusion
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturers: FEDERA Limoges SAS, Louviers Cedex, France
Fresenius Kabi Norge AS, Halden, Norway
Product: Dobuject
Active Ingredient: Dobutamine hydrochloride 56.05mg equivalent to dobutamine 50mg
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: BerliMed SA, Madrid, Spain
Product: I-Amlodipine
Active Ingredient: Amlodipine besilate 13.88mg equivalent to 10mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Silvassa, India
Product: I-Amlodipine
Active Ingredient: Amlodipine besilate 6.935mg equivalent to 5mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Silvassa, India
Product: Omezol Relief modified release (prescription)
Active Ingredient: Omeprazole 10mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India
Product: Omezol Relief modified release (restricted)
Active Ingredient: Omeprazole 10mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India
Product: Omezol Relief modified release
Active Ingredient: Omeprazole 20mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India
Product: Omezol Relief modified release
Active Ingredient: Omeprazole 40mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India
Product: Stavudine
Active Ingredient: Stavudine 1.05mg/mL
Dosage Form: Powder for oral solution
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Vedafil
Active Ingredient: Sildenafil citrate 140.483mg equivalent to sildenafil 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India
Product: Vedafil
Active Ingredient: Sildenafil citrate 35.121mg equivalent to sildenafil 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India
Product: Vedafil
Active Ingredient: Sildenafil citrate 70.241mg equivalent to sildenafil 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Matrix Laboratories Limited, Nashik, India
Dated this 16th day of September 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).