EMEA-002217-PIP01-17-M02 - paediatric investigation plan

in vitro expanded autologous human articular chondrocytes

Key facts

• Active substance:
  in vitro expanded autologous human articular chondrocytes
• Therapeutic area:
  Other
• Decision number:
  P/0315/2021
• PIP number:
  EMEA-002217-PIP01-17-M02
• Pharmaceutical form(s):
  Implant
• Condition(s) / indication(s):
  Treatment of cartilage disorders
• Route(s) of administration:
  Intraarticular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/08/2021
• Compliance check done:
  No

Decision

P/0315/2021 : EMA decision of 12 August 2021 on the refusal of a modification of an agreed paediatric investigation plan and on the refusal of a deferral and on the granting of a product-specific waiver for in vitro....(EMEA-002217-PIP01-17-M02)

Adopted Reference Number: EMA/428127/2021