EMEA-003193-PIP01-22 - paediatric investigation plan

Autologous bone marrow-derived mononuclear cell enriched white blood cells

Key facts

• Active Substance:
  Autologous bone marrow-derived mononuclear cell enriched white blood cells
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0224/2022
• PIP number:
  EMEA-003193-PIP01-22
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of chronic limb-threatening ischemia
• Route(s) of administration:
  All routes of administration
• Contact for public enquiries:

  Ixaka Iberia SLU

  E-Mail: [e-mail]

  Tel. [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/07/2022

Decision

P/0224/2022 : EMA decision of 8 July 2022 on the granting of a product specific waiver for autologous bone marrow-derived mononuclear cell enriched white blood cells (EMEA-003193-PIP01-22)

Reference Number: EMA/609069/2022