EMEA-000371-PIP01-08 - paediatric investigation plan

lenalidomide

Key facts

• Invented name:
  Revlimid
• Active substance:
  lenalidomide
• Therapeutic area:
  Oncology
• Decision number:
  P/102/2008
• PIP number:
  EMEA-000371-PIP01-08
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Myelodysplastic Syndrome
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  06/11/2008
• Compliance check done:
  No

Decision

P/102/2008: European Medicines Agency decision of 6 November 2008 on the application for product specific waiver for lenalidomide (Revlimid) (EMEA-000371-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the E...

Adopted Reference Number: EMEA/575498/2008