EMEA-002645-PIP03-21 - paediatric investigation plan

Sacituzumab govitecan

Key facts

• Invented name:
  Trodelvy
• Active Substance:
  Sacituzumab govitecan
• Therapeutic area:
  Oncology
• Decision number:
  P/0181/2022
• PIP number:
  EMEA-002645-PIP03-21
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of lung carcinoma (small cell and non-small cell carcinoma)
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/05/2022

Decision

P/0181/2022 : EMA decision of 13 May 2022 on the granting of a product specific waiver for sacituzumab govitecan (Trodelvy), (EMEA-002645-PIP03-21)

AdoptedReference Number: EMA/205815/2022