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: Healon 5
Active Ingredient(s): Sodium hyaluronate 5000 23mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmacia & Upjohn Limited Company
Manufacturer(s): Pharmacia & Upjohn AB, Uppsala, Sweden
Product: Miflasone
Active Ingredient(s): Beclomethasone dipropionate 100µg
Dosage Form: Powder filled inhalation capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Pharmachemie BV, Zaandam, The Netherlands
Product: Miflasone
Active Ingredient(s): Beclomethasone dipropionate 200µg
Dosage Form: Powder filled inhalation capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Pharmachemie BV, Zaandam, The Netherlands
Product: Miflasone
Active Ingredient(s): Beclomethasone dipropionate 400µg
Dosage Form: Powder filled inhalation capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Pharmachemie BV, Zaandam, The Netherlands
Product: Orzel (Combination Product)
Active Ingredient(s): Tegafur 100mg
Uracil 224mg
Dosage Form: Capsule
Manufacturer(s): Invamed Inc, Dayton, New Jersey, United States of America
Taiho Pharmaceutical Co Limited, Hiraishi, Kawauchi-cho, Tokushima-shi, Tokushima, Japan
Active Ingredient(s): Calcium folinate (anhydrous) 16.2mg equiv to 15 mg folinate
Dosage Form: Tablet
Manufacturer(s): Invamed Inc, Dayton, New Jersey, United States of America
Taiho Pharmaceutical Co Limited, Hiraishi, Kawauchi-cho, Tokushima-shi, Tokushima, Japan
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Product: UFT
Active Ingredient(s): Tegafur 100mg
Uracil 224mg
Dosage Form: Combination capsule
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer(s): Taiho Pharmaceutical Co Limited, Hiraishi, Kawauchi-cho, Tokushima-shi, Tokushima, Japan
Note: For use in combination only.
Dated this 6th day of September 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).