EMEA-001023-PIP01-10 - paediatric investigation plan

romidepsin

Key facts

• Active substance:
  romidepsin
• Therapeutic area:
  Oncology
• Decision number:
  P/40/2011
• PIP number:
  EMEA-001023-PIP01-10
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/02/2011
• Compliance check done:
  No

Decision

P/40/2011: EMA decision of 3 February 2011 on the granting of a product specific waiver for romidepsin (EMEA-001023-PIP01-10)

Adopted Reference Number: EMA/65907/2011