EMEA-000371-PIP02-09 - paediatric investigation plan

lenalidomide

Key facts

• Invented name:
  • Revlimid
  • Revlimid
• Active substance:
  lenalidomide
• Therapeutic area:
  Oncology
• Decision number:
  P/50/2011
• PIP number:
  EMEA-000371-PIP02-09
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of diffuse large B-cell lymphoma
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/03/2011
• Compliance check done:
  Nej

Decision

P/50/2011: EMA decision of 4 March 2011 on the granting of a product specific waiver for lenalidomide (Revlimid) (EMEA 000371-PIP02-09) in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of th...

Adopted Reference Number: EMA/157193/2011