EMEA-003648-PIP01-24 - paediatric investigation plan

ALK inhibitor (NVL-655)

Key facts

• Active substance:
  ALK inhibitor (NVL-655)
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0378/2024
• PIP number:
  EMEA-003648-PIP01-24
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of lung cancer (small cell and non-small cell 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:
  25/10/2024
• Compliance check done:
  No

Decision

P/0378/2024 : EMA decision of 25 October 2024 on the granting of a product specific waiver for ALK inhibitor (NVL-655) (EMEA-003648-PIP01-24)

Adopted Reference Number: EMA/465523/2024