EMEA-002841-PIP01-20 - paediatric investigation plan

fasudil hydrochloride

Key facts

• Active substance:
  fasudil hydrochloride
• Therapeutic area:
  Neurology
• Decision number:
  P/0468/2020
• PIP number:
  EMEA-002841-PIP01-20
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Concentrate for solution for injection
  • Powder for solution for injection or infusion
• Condition(s) / indication(s):
  Treatment of non-traumatic subarachnoid haemorrhage
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/12/2020
• Compliance check done:
  No

Decision

P/0468/2020 : EMA decision of 1 December 2020 on the granting of a product specific waiver for fasudil (hydrochloride) (EMEA-002841-PIP01-20)

Adopted Reference Number: EMA/621031/2020