EMEA-003415-PIP01-23 - paediatric investigation plan

sotuletinib

Key facts

• Active substance:
  sotuletinib
• Therapeutic area:
  Neurology
• Decision number:
  P/0317/2023
• PIP number:
  EMEA-003415-PIP01-23
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of amyotrophic lateral sclerosis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/08/2023
• Compliance check done:
  No

Decision

P/0317/2023 : EMA decision of 9 August 2023 on the granting of a product specific waiver for sotuletinib (EMEA-003415-PIP01-23)

Reference Number: EMA/336122/2023