EMEA-003456-PIP01-23 - paediatric investigation plan

2-[3-(dimethyl-1H-1,2,3-triazol-5-yl)-5-[(S)-oxan-4-yl(phenyl)methyl]-5H-pyrido[3,2-b]indol-7-yl]propan-2-ol

Key facts

• Active Substance:
  2-[3-(dimethyl-1H-1,2,3-triazol-5-yl)-5-[(S)-oxan-4-yl(phenyl)methyl]-5H-pyrido[3,2-b]indol-7-yl]propan-2-ol
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0427/2023
• PIP number:
  EMEA-003456-PIP01-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of myelofibrosis
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/10/2023

Decision

P/0427/2023 : EMA decision of 27 October 2023 on the granting of a product specific waiver for 2-[3-(dimethyl-1H-1,2,3-triazol-5-yl)-5-[(S)-oxan-4- yl(phenyl)methyl]-5H-pyrido[3,2-b]indol-7-yl]propan-2-ol, (EMEA-003456-PIP01-23)

AdoptedReference Number: EMA/469615/2023