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: Acihexal 5%
Active Ingredient: Aciclovir 5%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Hexal New Zealand Pty Limited
Manufacturer: Soul Pattinson Manufacturing Pty Limited, Kingsgrove, New South Wales, Australia
Product: Actos
Active Ingredient: Pioglitazone hydrochloride 16.53mg equivalent to 15mg pioglitazone
Dosage Form: Tablet
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturers: Takeda Chemical Industries Limited, Yodogawa-ku, Osaka, Japan
Takeda Ireland Limited, Kilruddery, County Wicklow, Ireland
Product: Actos
Active Ingredient: Pioglitazone hydrochloride 33.06mg equivalent to 30mg pioglitazone
Dosage Form: Tablet
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturers: Takeda Chemical Industries Limited, Yodogawa-ku, Osaka, Japan
Takeda Ireland Limited, Kilruddery, County Wicklow, Ireland
Product: Actos
Active Ingredient: Pioglitazone hydrochloride 49.59mg equivalent to 45mg pioglitazone
Dosage Form: Tablet
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturers: Takeda Chemical Industries Limited, Yodogawa-ku, Osaka, Japan
Takeda Ireland Limited, Kilruddery, County Wicklow, Ireland
Product: Elidel
Active Ingredient: Pimecrolimus 10mg
Dosage Form: Topical cream
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma GmbH, Wehr, Germany
Dated this 29th day of May 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).