EMEA-003269-PIP01-22 - paediatric investigation plan

2-{4-[4-(4-{5-[(1S)-1-amino-1-(4-fluorophenyl) ethyl]pyrimidin-2-yl}piperazin-1-yl)pyrrolo[2,1-f] [1,2,4]triazin-6-yl]-1H-pyrazol-1-yl}ethan-1-ol

Key facts

• Active substance:
  2-{4-[4-(4-{5-[(1S)-1-amino-1-(4-fluorophenyl) ethyl]pyrimidin-2-yl}piperazin-1-yl)pyrrolo[2,1-f] [1,2,4]triazin-6-yl]-1H-pyrazol-1-yl}ethan-1-ol
• Therapeutic area:
  • Haematology-Hemostaseology
  • Oncology
• Decision number:
  P/0479/2022
• PIP number:
  EMEA-003269-PIP01-22
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of mastocytosis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  02/12/2022
• Compliance check done:
  No

Decision

P/0479/2022: EMA decision of 2 December 2022 on the granting of a product specific waiver for 2-{4-[4-(4-{5-[(1S)-1-amino-1-(4-fluorophenyl) ethyl]pyrimidin-2-yl}piperazin-1-yl)pyrrolo[2,1-f] [...](EMEA-003269-PIP01-22)

Adopted Reference Number: EMA/899042/2022