Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicines which were referred to the Minister of Health under the provisions of section 24 (5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Remicade
Active Ingredient: Infliximab 100mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturers: Parkedale Pharmaceuticals Inc, Rochester, Michigan, United States of America
Patheon Italia SpA, Stucchi, Monza, Italy
Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: Tramal 100
Active Ingredient: Tramadol hydrochloride 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: CSL New Zealand Limited
Manufacturer: Grunenthal GmbH, Stolberg, Germany
Product: Tramal 50
Active Ingredient: Tramadol hydrochloride 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: CSL New Zealand Limited
Manufacturer: Grunenthal GmbH, Stolberg, Germany
Product: Tramal Oral Drops
Active Ingredient: Tramadol hydrochloride 100mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: CSL New Zealand Limited
Manufacturer: Grunenthal GmbH, Stolberg, Germany
Dated this 23rd day of November 2006.
BARRY BORMAN, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).