EMEA-003598-PIP01-24 - paediatric investigation plan

anti-human LAG-3 monoclonal antibody, human IgG4 isotype

Key facts

• Active substance:
  anti-human LAG-3 monoclonal antibody, human IgG4 isotype
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0256/2024
• PIP number:
  EMEA-003598-PIP01-24
• 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:
  19/07/2024
• Compliance check done:
  No

Decision

P/0256/2024: EMA decision of 19 July 2024 on the granting of a product specific waiver for anti-human LAG-3 monoclonal antibody, human IgG4 isotype (EMEA-003598-PIP01-24)

Adopted Reference Number: EMA/296479/2024