EMEA-001450-PIP01-13-M01 - paediatric investigation plan

vosaroxin

Key facts

• Active Substance:
  vosaroxin
• Therapeutic area:
  Oncology
• Decision number:
  P/0296/2015
• PIP number:
  EMEA-001450-PIP01-13-M01
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of acute myeloid leukaemia
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Sunesis Europe Ltd

  Belgium; Tel. [phone] ; Fax [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/12/2015

Decision

P/0296/2015: EMA decision of 4 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for vosaroxin (EMEA-001450-PIP01-13-M01)

AdoptedReference Number: EMA/785820/2015