EMEA-000371-PIP04-16 - paediatric investigation plan

lenalidomide

Key facts

• Invented name:
  • Revlimid
  • Revlimid
• Active substance:
  lenalidomide
• Therapeutic area:
  Oncology
• Decision number:
  EMEA-000371-PIP04-16
• PIP number:
  EMEA-000371-PIP04-16
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of mature B-cell neoplasms
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/10/2017
• Compliance check done:
  No

Decision

P/0279/2017: EMA decision of 4 October 2017 on the granting of a product specific waiver for lenalidomide (Revlimid) (EMEA-000371-PIP04-16)

Reference Number: EMA/565633/2017