EMEA-001150-PIP03-22 - paediatric investigation plan

rapibloc

landiobloc

raploc

runrapiq

Key facts

• Active Substance:
  • rapibloc
  • landiobloc
  • raploc
  • runrapiq
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0015/2023
• PIP number:
  EMEA-001150-PIP03-22
• Pharmaceutical form(s):
  • Concentrate for solution for injection
  • Powder for solution for infusion
• Condition(s) / indication(s):
  Treatment of ventricular tachycardia and ventricular fibrillation
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  AOP Orphan Pharmaceuticals AG

  Austria ; E-mail: [e-mail] ; Tel. [phone] ; Fax [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2023

Decision

P/0015/2023 : EMA decision of 31 January 2023 on the granting of a product specific waiver for landiolol (hydrochloride) (Rapibloc, Landiobloc, Raploc, Runrapiq), (EMEA-001150-PIP03-22)

Reference Number: EMA/18675/2023