EMEA-003371-PIP01-22 - paediatric investigation plan

N-(4-(4-amino-5-(3-fluoro-4-((4-methylpyrimidin-2- yl)oxy)phenyl)-7-methyl-7H-pyrrolo[2,3-d] pyrimidin-6-yl)phenyl)methacrylamide (hydrochloride) (RLY-4008)

Key facts

• Active substance:
  N-(4-(4-amino-5-(3-fluoro-4-((4-methylpyrimidin-2- yl)oxy)phenyl)-7-methyl-7H-pyrrolo[2,3-d] pyrimidin-6-yl)phenyl)methacrylamide (hydrochloride) (RLY-4008)
• Therapeutic area:
  Oncology
• Decision number:
  P/0154/2023
• PIP number:
  EMEA-003371-PIP01-22
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of cholangiocarcinoma
• 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:
  12/05/2023
• Compliance check done:
  No

Decision

P/0154/2023 : EMA decision of 12 May 2023 on the granting of a product specific waiver for N-(4-(4-amino-5-(3-fluoro-4-((4-methylpyrimidin-2- yl)oxy)phenyl)...(EMEA-003371-PIP01-22)

Reference Number: EMA/170256/2023