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: Conthram Forte
Active Ingredients: Danthron 15mg/mL
Poloxamer 188 200mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Pacific Pharmaceuticals Limited, Mt Wellington, Auckland
This consent is given subject to the following conditions:
? This medicine may only be used for the prevention of constipation in the terminally ill.
Note: This consent is valid for two years from the 19 October 2002.
Product: Conthram
Active Ingredients: Danthron 5mg/mL
Poloxamer 188 40mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Pacific Pharmaceuticals Limited, Mt Wellington, Auckland
This consent is given subject to the following conditions:
? This medicine may only be used for the prevention of constipation in the terminally ill.
Note: This consent is valid for two years from 19 October 2002.
Product: Pentaspan
Active Ingredient: Poly-O-(2-hydroxyethyl)-starch 100mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Boots Healthcare Medical N Z Div. Boots Healthcare Australia
Manufacturer: NPBI BV, Runde, Emmer-Compascuum, The Netherlands
Note: This consent is valid for two years from 20 April 2002.
Product: Prothrombinex-HT
Active Ingredients: Factor II 500IU
Factor IX 500IU
Factor X 500IU
Dosage Form: Powder for injection
New Zealand Sponsor: CSL (New Zealand) Limited
Manufacturer: CSL Limited, Broadmeadows, Victoria, Australia
Note: This consent is valid for two years from 3 December 2002.
Dated this 18th day of July 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).