EMEA-002213-PIP01-17 - paediatric investigation plan

sirolimus

Key facts

• Active substance:
  sirolimus
• Therapeutic area:
  Other
• Decision number:
  P/0395/2017
• PIP number:
  EMEA-002213-PIP01-17
• Pharmaceutical form(s):
  Implant
• Condition(s) / indication(s):
  Prevention of arteriovenous access dysfunction
• Route(s) of administration:
  Implantation
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  19/12/2017
• Compliance check done:
  No

Decision

P/0395/2017: EMA decision of 19 December 2017 on the granting of a product specific waiver for sirolimus (EMEA-002213-PIP01-17)

Reference Number: EMA/771137/2017