EMEA-003383-PIP02-23 - paediatric investigation plan

Inhibitor of receptor-interacting serine/threonine-protein kinase 1 (SAR443820)

Key facts

• Active substance:
  Inhibitor of receptor-interacting serine/threonine-protein kinase 1 (SAR443820)
• Therapeutic area:
  Neurology
• Decision number:
  P/0218/2023
• PIP number:
  EMEA-003383-PIP02-23
• Pharmaceutical form(s):
  Film-coated tablet
• 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:
  14/06/2023
• Compliance check done:
  No

Decision

P/0218/2023 : EMA decision of 14 June 2023 on the granting of a product specific waiver for inhibitor of receptor-interacting serine/threonineprotein kinase 1 (SAR443820) (EMEA-003383-PIP02-23)

Reference Number: EMA/236613/2023