EMEA-001594-PIP02-13 - paediatric investigation plan

Tirasemtiv

Key facts

• Active Substance:
  Tirasemtiv
• Therapeutic area:
  Neurology
• Decision number:
  P/0208/2014
• PIP number:
  EMEA-001594-PIP02-13
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of amyotrophic lateral sclerosis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  NDA Group

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/08/2014

Decision

P/0208/2014: EMA decision of 8 August 2014 on the granting of a product specific waiver for tirasemtiv (EMEA-001594-PIP02-13)

AdoptedReference Number: EMA/439330/2014