Fluorouracil / salicylic acid - paediatric investigation plan

Fluorouracil

salicylic acid

Key facts

• Active substance:
  • Fluorouracil
  • salicylic acid
• Therapeutic area:
  Dermatology
• Decision number:
  P/241/2009
• PIP number:
  Fluorouracil / salicylic acid
• Pharmaceutical form(s):
  Solution
• Condition(s) / indication(s):
  Treatment of actinic keratosis
• Route(s) of administration:
  Cutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/12/2009
• Compliance check done:
  No

Decision

P/241/2009: EMA decision of 1 December 2009 on the granting of a product specific waiver for fluorouracil / salicylic acid (EMEA-000650-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of ...

Adopted Reference Number: EMEA/760603/2009