EMA/PE/0000182928 - paediatric investigation plan

propranolol hydrochloride

Key facts

• Active substance:
  propranolol hydrochloride
• Therapeutic area:
  Cardiac disorders
• Decision number:
  EMA/PE/0000182928
• PIP number:
  EMA/PE/0000182928
• Pharmaceutical form(s):
  Orodispersible tablet
• Condition(s) / indication(s):
  Treatment of arrhythmias
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/04/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000182928 : EMA decision of 15 April 2025 on the agreement of a paediatric investigation plan for propranolol hydrochloride

Adopted Reference Number: EMADOC-1700519818-2038862