Bortezomib - paediatric investigation plan

bortezomib

Key facts

• Invented name:
  • Velcade
  • Velcade
• Active substance:
  bortezomib
• Therapeutic area:
  Oncology
• Decision number:
  P/78/2008
• PIP number:
  Bortezomib
• Pharmaceutical form(s):
  Powder for solution for injection
• 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:
  14/09/2008
• Compliance check done:
  Nē

Decision

P/78/2008: European medicines agency decision of 14 September 2008 on the application for product specific waiver for bortezomib (Velcade) EMEA-000233-PIP01-08 in accordance with Regulation (EC) No 1901/2006 of the Eur...

Adopted Reference Number: EMEA/466976/2008