EMEA-002868-PIP01-20 - paediatric investigation plan

Reldesemtiv

Key facts

• Active Substance:
  Reldesemtiv
• Therapeutic area:
  Neurology
• Decision number:
  P/0025/2021
• PIP number:
  EMEA-002868-PIP01-20
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of amyotrophic lateral sclerosis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Cytokinetics, Inc.

  Tel.: [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/01/2021

Decision

P/0025/2021 : EMA decision of 28 January 2021 on the granting of a product specific waiver for reldesemtiv (EMEA-002868-PIP01-20)

AdoptedReference Number: EMA/694640/2020