EMEA-002378-PIP01-18 - paediatric investigation plan

N-hydroxy-5-methylfuran-2-sulfonamide (BMS-986231)

Key facts

• Active substance:
  N-hydroxy-5-methylfuran-2-sulfonamide (BMS-986231)
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0110/2019
• PIP number:
  EMEA-002378-PIP01-18
• Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
  • Age appropriate dosage form for parenteral use
• Condition(s) / indication(s):
  Treatment of acute heart failure
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  22/03/2019
• Compliance check done:
  No

Decision

P/0110/2019: EMA decision of 22 March 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral for N-hydroxy-5-methylfuran-2-sulfonamide (BMS-986231) (EMEA-002378-PIP01-18)

Adopted Reference Number: EMA/173738/2019