EMEA-000979-PIP01-10-M02 - paediatric investigation plan

Matrix applied characterised autologous cultured chondrocytes

Key facts

• Invented name:
  • Maci
  • Maci
• Active Substance:
  Matrix applied characterised autologous cultured chondrocytes
• Therapeutic area:
  Other
• Decision number:
  P/0012/2018
• PIP number:
  EMEA-000979-PIP01-10-M02
• Pharmaceutical form(s):
  Implant
• Condition(s) / indication(s):
  Treatment of cartilage disorders
• Route(s) of administration:
  Implant use
• Contact for public enquiries:

  Vericel Denmark ApS

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/01/2018

Decision

P/0012/2018: EMA decision of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for matrix applied characterised autologous cultured chondrocytes (MACI) (EMEA-000979-PIP01-10-...

Reference Number: EMA/28037/2018