EMEA-001921-PIP01-16 - paediatric investigation plan

mirvetuximab soravtansine

Key facts

• Active substance:
  mirvetuximab soravtansine
• Therapeutic area:
  Oncology
• Decision number:
  P/0032/2017
• PIP number:
  EMEA-001921-PIP01-16
• Pharmaceutical form(s):
  Solution for injection/infusion
• Condition(s) / indication(s):
  • Treatment of fallopian tube cancer
  • Treatment of ovarian carcinoma
  • Treatment of peritoneal carcinoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2017
• Compliance check done:
  Nein

Decision

P/0032/2017: European Medicines Agency decision of 31 January 2017 on the granting of a product specific waiver for mirvetuximab soravtansine (EMEA-001921-PIP01-16)

Adopted Reference Number: EMA/12265/2017