EMEA-002356-PIP02-20-M01 - paediatric investigation plan

voxelotor

Key facts

• Invented name:
  Oxbryta
• Active substance:
  voxelotor
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0491/2022
• PIP number:
  EMEA-002356-PIP02-20-M01
• Pharmaceutical form(s):
  • Tablet
  • Dispersible tablet
• Condition(s) / indication(s):
  Treatment of sickle cell disease
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  02/12/2022
• Compliance check done:
  No

Decision

P/0491/2022 : EMA decision of 2 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for voxelotor (EMEA- 002356-PIP02-20-M01)

Adopted Reference Number: EMA/853094/2022