EMEA-003467-PIP01-23 - paediatric investigation plan

gotistobart

Key facts

• Active Substance:
  gotistobart
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0498/2023
• PIP number:
  EMEA-003467-PIP01-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of lung cancer
• 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:
  01/02/2023

Decision

P/0498/2023 : EMA decision of 1 December 2023 on the granting of a product specific waiver for gotistobart, (EMEA-003467-PIP01-23)

AdoptedReference Number: EMA/517080/2023