Notice Type
Departmental
Renewal of Provisional Consent to the Distribution of a New Medicine Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto: Schedule Product: Actigall. Active Ingredient(s): Ursodeoxycholic acid 150 mg. Dosage Form: Capsule. NZ Sponsor: Novartis New Zealand Limited. Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland. Novartis Pharmaceuticals Corporation, New York, U.S.A. Note: This consent is valid for 2 years from the 7th day of September 1999. Product: Actigall. Active Ingredient(s): Ursodeoxycholic acid 300 mg. Dosage Form: Capsule. NZ Sponsor: Novartis New Zealand Limited. Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland. Novartis Pharmaceuticals Corporation, New York, U.S.A. Note: This consent is valid for 2 years from the 7th day of September 1999. Product: Exelon. Active Ingredient(s): Rivastigmine (as hydrogen tartrate) 0.8 mg equivalent to 0.5 mg rivastigmine. Dosage Form: Capsule. NZ Sponsor: Novartis New Zealand Limited. Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland. Note: This consent is valid for 2 years from 13th day of November 1999. Product: Exelon. Active Ingredient(s): Rivastigmine (as hydrogen tartrate) 1.6 mg equivalent to 1 mg rivastigmine. Dosage Form: Capsule. NZ Sponsor: Novartis New Zealand Limited. Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland. Note: This consent is valid for 2 years from 13th day of November 1999. Product: Exelon. Active Ingredient(s): Rivastigmine (as hydrogen tartrate) 2.4 mg equivalent to 1.5 mg rivastigmine. Dosage Form: Capsule. NZ Sponsor: Novartis New Zealand Limited. Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland. Note: This consent is valid for 2 years from 13th day of November 1999. Product: Exelon. Active Ingredient(s): Rivastigmine (as hydrogen tartrate) 4.8 mg equivalent to 3 mg rivastigmine. Dosage Form: Capsule. NZ Sponsor: Novartis New Zealand Limited. Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland. Note: This consent is valid for 2 years from 13th day of November 1999. Product: Exelon. Active Ingredient(s): Rivastigmine (as hydrogen tartrate) 7.2 mg equivalent to 4.5 mg rivastigmine. Dosage Form: Capsule. NZ Sponsor: Novartis New Zealand Limited. Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland. Note: This consent is valid for 2 years from 13th day of November 1999. Product: Exelon. Active Ingredient(s): Rivastigmine (as hydrogen tartrate) 9.6 mg equivalent to 6 mg rivastigmine. Dosage Form: Capsule. NZ Sponsor: Novartis New Zealand Limited. Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland. Note: This consent is valid for 2 years from 13th day of November 1999. Dated this 6th day of September 1999. G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).
Publication Date
9 Sep 1999

Notice Number

1999-go6614

Page Number

2731