Flosfluridine tidoxil - paediatric investigation plan

Flosfluridine tidoxil

Key facts

• Active Substance:
  Flosfluridine tidoxil
• Therapeutic area:
  Dermatology
• Decision number:
  P/15/2008
• PIP number:
  Flosfluridine tidoxil
• Pharmaceutical form(s):
  Capsule
• Condition(s) / indication(s):
  Treatment of actinic keratosis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Heidelberg Pharma AG

  E-mail: [e-mail]; Country: Germany; Phone: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/03/2008

Decision

P/15/2008: European medicines agency decision of 31 March 2008 on the application for product-specific waiver for fosfluridine tidoxil (EMEA-000094-PIP01-07) in accordance with Regulation (EC) No 1901/2006 of the Europea...

AdoptedReference Number: EMEA/155447/2008