Medicines Approval Notices




14 SEPTEMBER NEW ZEALAND GAZETTE 3297

Product: Miflasonе
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).

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Consent to the Distribution of New Medicines

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: Apo-Moclobemide
Active Ingredient(s): Moclobemide 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Apotex Inc, Weston, Ontario, Canada

Product: Apo-Moclobemide
Active Ingredient(s): Moclobemide 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Apotex Inc, Weston, Ontario, Canada

Product: Paracetamol (Signature Range)
Active Ingredient(s): Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: PSM Healthcare Limited
Manufacturer(s): PSM Healthcare Limited, Wiri, Auckland

Product: Paracetamol (Signature Range)
Active Ingredient(s): Paracetamol 500mg
Dosage Form: Capsule
New Zealand Sponsor: PSM Healthcare Limited
Manufacturer(s): PSM Healthcare Limited, Wiri, Auckland

Dated this 31st day of August 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).

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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2000, No 130


Gazette.govt.nz PDF NZ Gazette 2000, No 130





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines (continued from previous page)

🏥 Health & Social Welfare
6 September 2000
Medicines, Distribution, Miflasonе, Orzel, UFT, Beclomethasone dipropionate, Tegafur, Uracil, Calcium folinate
  • G. R. Boyd, Chief Advisor, Safety and Regulation

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
31 August 2000
Medicines, Distribution, Apo-Moclobemide, Paracetamol, Moclobemide
  • G. R. Boyd, Chief Advisor, Safety and Regulation