EMEA-002431-PIP01-18 - paediatric investigation plan

alectinib

Key facts

• Invented name:
  Alecensa
• Active Substance:
  alectinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0359/2018
• PIP number:
  EMEA-002431-PIP01-18
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of non-small cell lung carcinoma (NSCLC)
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/12/2018

Decision

P/0359/2018: EMA decision of 7 December 2018 on the granting of a product specific waiver for alectinib (Alecensa), (EMEA-002431-PIP01-18)

AdoptedReference Number: EMA/797212/2018