EMEA-001150-PIP02-13-M05 - paediatric investigation plan

Landiolol (hydrochloride)

Key facts

• Invented name:
  • Rapibloc
  • Landiobloc
  • Raploc
  • Runrapiq
• Active Substance:
  Landiolol (hydrochloride)
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0221/2023
• PIP number:
  EMEA-001150-PIP02-13-M05
• Pharmaceutical form(s):
  • Powder for solution for injection
  • Concentrate for solution for injection
• Condition(s) / indication(s):
  Treatment of supraventricular arrhythmias
• Route(s) of administration:
  • Intravenous use
  • Intravenous bolus use
• Contact for public enquiries:

  AOP Orphan Pharmaceuticals AG; E-mail: [e-mail]; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2023

Decision

P/0221/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for landiolol (hydrochloride) (Rapibloc, Landiobloc, Raploc, Runrapiq), (EMEA-001150-PIP02-13-M05)

Reference Number: EMA/236236/2023