EMEA-002669-PIP02-20 - paediatric investigation plan

Lorlatinib

Key facts

• Invented name:
  Lorviqua
• Active substance:
  Lorlatinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0006/2021
• PIP number:
  EMEA-002669-PIP02-20
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of lung cancer
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/01/2021
• Compliance check done:
  No

Decision

P/0006/2021 : EMA decision of 15 January 2021 on the granting of a product specific waiver for lorlatinib (Lorviqua) (EMEA-002669-PIP02-20)

Adopted Reference Number: EMA/11995/2021