EMEA-001121-PIP01-10 - paediatric investigation plan

Elacytarabine

Key facts

• Active Substance:
  Elacytarabine
• Therapeutic area:
  Oncology
• Decision number:
  P/0043/2012
• PIP number:
  EMEA-001121-PIP01-10
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of acute myeloid leukaemia
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Clavis Pharma ASA

  Norway ; [e-mail] ; [phone] ; [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  28/02/2012

Decision

P/43/2012: EMA decision of 28 February 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for elacytarabine (EMEA-001121-PIP01-10)

AdoptedReference Number: EMA/130187/2012