EMEA-000026-PIP02-11 - paediatric investigation plan

temsirolimus

Key facts

• Invented name:
  • Torisel
  • Torisel
• Active substance:
  temsirolimus
• Therapeutic area:
  Oncology
• Decision number:
  P/262/2011
• PIP number:
  EMEA-000026-PIP02-11
• Pharmaceutical form(s):
  Concentrate and diluent for solution for infusion
• Condition(s) / indication(s):
  Treatment of mantle cell lymphoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/10/2011
• Compliance check done:
  Nej

Decision

P/262/2011: EMA decision of 28 October 2011 on the granting of a product specific waiver for temsirolimus (Torisel) (EMEA-000026-PIP02-11)

Adopted Reference Number: EMA/846762/2011