EMEA-002148-PIP01-17 - paediatric investigation plan

5, 7-dihydroxy-2-[3-hydroxy-4-methoxy-2-(2-methyl-2-propenyl) phenyl]-6, 8-bis (2-methyl-2-propenyl)-4H-chromen-4-one

Key facts

• Active substance:
  5, 7-dihydroxy-2-[3-hydroxy-4-methoxy-2-(2-methyl-2-propenyl) phenyl]-6, 8-bis (2-methyl-2-propenyl)-4H-chromen-4-one
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0221/2017
• PIP number:
  EMEA-002148-PIP01-17
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of venous and mixed (venous/arterial) leg ulcers
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/08/2017
• Compliance check done:
  No

Decision

P/0221/2017: EMA decision of 11 August 2017 on the granting of a product specific waiver for 5, 7-dihydroxy-2-[3-hydroxy-4-methoxy-2-(2-methyl- 2-propenyl) phenyl]-6, 8-bis (2-methyl-2-propenyl)-4H-chromen-4-one (EMEA-0...

Adopted Reference Number: EMA/460050/2017