EMEA-001264-PIP01-12-M02 - paediatric investigation plan

spheroids of human autologous matrix-associated chondrocytes

Key facts

• Invented name:
  Spherox
• Active substance:
  spheroids of human autologous matrix-associated chondrocytes
• Therapeutic area:
  Other
• Decision number:
  P/0161/2018
• PIP number:
  EMEA-001264-PIP01-12-M02
• Pharmaceutical form(s):
  Implantation suspension
• Condition(s) / indication(s):
  Treatment of cartilage disorders
• Route(s) of administration:
  Intra-articular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/06/2018
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001264-PIP01-12-M02
• Compliance opinion date:
  24/07/2020
• Compliance outcome:
  Positive

Decision

P/0161/2018: EMA decision of 15 June 2018 on the acceptance of a modification of an agreed paediatric investigation plan for spheroids of human autologous matrix-associated chondrocytes (Spherox), (EMEA-001264-PIP01-12-M02)

Adopted Reference Number: EMA/324452/2018