EMEA-003345-PIP01-22 - paediatric investigation plan

acellular tubular graft composed of human collagen types I and III and other extracellular matrix proteins, including fibronectin and vitronectin

Key facts

• Active substance:
  acellular tubular graft composed of human collagen types I and III and other extracellular matrix proteins, including fibronectin and vitronectin
• Therapeutic area:
  Other
• Decision number:
  P/0355/2023
• PIP number:
  EMEA-003345-PIP01-22
• Pharmaceutical form(s):
  Implant
• Condition(s) / indication(s):
  Treatment of vascular injuries
• Route(s) of administration:
  Implant use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/09/2023
• Compliance check done:
  No

Decision

P/0355/2023: EMA decision of 8 September 2023 on the granting of a product specific waiver for acellular tubular graft composed of human collagen types I and III and other extracellular matrix proteins, including fibronectin and vitronectin (EMEA- 003345-

Adopted Reference Number: EMA/380491/2023