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: Claratyne Liqui-Gels
Active Ingredient: Loratadine 10mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Catalent Pharma Solutions LLC, Florida, United States of America
Product: Clopidev
Active Ingredient: Clopidogrel besilate 111.85mg equivalent to 75mg clopidogrel
Dosage Form: Film coated tablet
New Zealand Sponsor: Deva Holdings NZ Limited
Manufacturer: Acino Pharma AG, Liesberg, Switzerland
Product: Duropatch
Active Ingredient: Fentanyl 1.28mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Technologies, Vermont, United States of America
Product: Duropatch
Active Ingredient: Fentanyl 2.55mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Technologies, Vermont, United States of America
Product: Duropatch
Active Ingredient: Fentanyl 5.1mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Technologies, Vermont, United States of America
Product: Duropatch
Active Ingredient: Fentanyl 7.65mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Technologies, Vermont, United States of America
Product: Duropatch
Active Ingredient: Fentanyl 10.2mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Technologies, Vermont, United States of America
Product: Granisetron
Active Ingredient: Granisetron hydrochloride 0.112mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Granisetron
Active Ingredient: Granisetron hydrochloride 1.12mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Zidovudine
Active Ingredient: Zidovudine 10mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Dated this 13th day of August 2010.
STEWART JESSAMINE, Acting Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).