EMEA-000720-PIP01-09-M02 - paediatric investigation plan

anagrelide

Key facts

• Invented name:
  • Xagrid
  • Xagrid
• Active substance:
  anagrelide
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0325/2013
• PIP number:
  EMEA-000720-PIP01-09-M02
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of essential thrombocythaemia
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  19/12/2013
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-000720-PIP01-09-M02
• Compliance opinion date:
  14/02/2014
• Compliance outcome:
  Positive

Decision

P/325/2013: EMA decision of 19 December 2013 on the acceptance of a modification of an agreed paediatric investigation plan for anagrelide (Xagrid) (EMEA-000720-PIP01-09-M02)

Adopted Reference Number: EMA/776034/2013