EMEA-001694-PIP01-14 - paediatric investigation plan

Autologous bone marrow-derived cardiopoietic stem cells

Key facts

• Active Substance:
  Autologous bone marrow-derived cardiopoietic stem cells
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0077/2015
• PIP number:
  EMEA-001694-PIP01-14
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Treatment of ischemic heart disease
• Route(s) of administration:
  Intracardiac use
• Contact for public enquiries:

  Cardio3 BioSciences SA

  Belgium; E-mail: [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:
  01/04/2015

Decision

P/0077/2015: EMA decision of 1 April 2015 on the granting of a product-specific waiver for autologous bone marrow-derived cardiopoietic stem cells (EMEA-001694-PIP01-14)

AdoptedReference Number: EMA/108893/2015