EMEA-000013-PIP01-07-M03 - paediatric investigation plan

recombinant L-asparaginase

Key facts

• Active substance:
  recombinant L-asparaginase
• Therapeutic area:
  Oncology
• Decision number:
  P/0084/2013
• PIP number:
  EMEA-000013-PIP01-07-M03
• Pharmaceutical form(s):
  Powder for solution for injection or infusion
• Condition(s) / indication(s):
  • Treatment of acute lymphoblastic leukaemia
  • Treatment of lymphoblastic lymphoma
• Route(s) of administration:
  • Intravenous use
  • Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/04/2013
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000013-PIP01-07-M03
• Compliance opinion date:
  14/06/2013
• Compliance outcome:
  Positive

Decision

P/0084/2013: EMA decision of 29 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant L-asparaginase (EMEA-000013-PIP01-07-M03)

Adopted Reference Number: EMA/187814/2013