EMEA-001329-PIP01-12 - paediatric investigation plan

Expanded autologous bone marrow-derived osteoblastic cells

Key facts

• Active Substance:
  Expanded autologous bone marrow-derived osteoblastic cells
• Therapeutic area:
  Other
• Decision number:
  P/0311/2012
• PIP number:
  EMEA-001329-PIP01-12
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  • Treatment of non-union fracture
  • Treatment of osteonecrosis
• Route(s) of administration:
  Intraosseous use
• Contact for public enquiries:

  Bone Therapeutics S.A.

  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:
  21/12/2012

Decision

P/0311/2012: EMA decision of 21 December 2012 on the granting and on the refusal of a product-specific waiver for expanded autologous bone-marrow-derived osteoblastic cells (EMEA-001329-PIP01-12)

AdoptedReference Number: EMA/811258/2012