EMEA-001823-PIP01-15-M03 - paediatric investigation plan

in vitro expanded autologous human articular chondrocytes

Key facts

• Active substance:
  in vitro expanded autologous human articular chondrocytes
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  P/0114/2024
• PIP number:
  EMEA-001823-PIP01-15-M03
• Pharmaceutical form(s):
  Implantation matrix
• 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:
  12/04/2024
• Compliance check done:
  No

Decision

P/0114/2024: EMA decision of 12 April 2024 on the acceptance of a modification of an agreed paediatric investigation plan for in vitro expanded autologous human articular chondrocytes (EMEA-001823-PIP01-15-M03)

Adopted Reference Number: EMA/121889/2024