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: Arava
Active Ingredient: Leflunomide 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer: Usiphar, Compeigne, France
Note: This consent is valid for two years from 23 March 2004.
Product: Arava
Active Ingredient: Leflunomide 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer: Usiphar, Compeigne, France
Note: This consent is valid for two years from 23 March 2004.
Product: Arava
Active Ingredient: Leflunomide 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer: Usiphar, Compeigne, France
Note: This consent is valid for two years from 23 March 2004.
Product: Codalax Forte
Active Ingredients: Danthron 15mg/mLPoloxamer 188 200mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Pharmaceuticals Limited, Lincoln, Auckland
This consent is given subject to the following condition:
? This medicine may only be used for the prevention or treatment of constipation in the terminally ill.
Note: This consent is valid for two years from 30 July 2004.
Product: Codalax
Active Ingredients: Danthron 5mg/mLPoloxamer 188 40mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacture: Douglas Pharmaceuticals Limited, Lincoln, Auckland
This consent is given subject to the following condition:
? This medicine may only be used for the prevention or treatment of constipation in the terminally ill.
Note: This consent is valid for two years from 30 July 2004.
Product: Pentaspan
Active Ingredient: Poly-O-(2-hydroxyethyl)-starch 100mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Boots Healthcare New Zealand Limited
Manufacturer: NPBI BV, Emmer-Compascuum, The Netherlands
Note: This consent is valid for two years from 20 April 2004.
Dated this 4th day of March 2004.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).