EMEA-001103-PIP01-10-M03 - paediatric investigation plan

deferasirox

Key facts

• Invented name:
  • Exjade
  • Exjade
• Active substance:
  deferasirox
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0175/2016
• PIP number:
  EMEA-001103-PIP01-10-M03
• Pharmaceutical form(s):
  • Dispersible tablet
  • Film-coated tablet
  • Granules
• Condition(s) / indication(s):
  Treatment of chronic iron overload requiring chelation therapy
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/06/2016
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001103-PIP01-10-M03
• Compliance opinion date:
  14/10/2016
• Compliance outcome:
  Positive

Decision

P/0175/2016: EMA decision of 30 June 2016 on the acceptance of a modification of an agreed paediatric investigation plan for deferasirox (Exjade), (EMEA-001103-PIP01-10-M03)

Adopted Reference Number: EMA/398390/2016