EMEA-001272-PIP02-13-M01 - paediatric investigation plan

azacitidine

Key facts

• Invented name:
  • Vidaza
  • Vidaza
• Active Substance:
  azacitidine
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0217/2015
• PIP number:
  EMEA-001272-PIP02-13-M01
• Pharmaceutical form(s):
  • Powder for suspension for injection
  • Powder for solution for infusion
• Condition(s) / indication(s):
  • Treatment of myelodysplastic syndrome (including juvenile myelomonocytic leukaemia)
  • Treatment of acute myeloid leukaemia
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Contact for public enquiries:

  Celgene Europe Ltd

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  02/10/2015

Decision

P/0217/2015: EMA decision of 2 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for azacitidine (Vidaza), (EMEA-001272-PIP02-13-M01)

AdoptedReference Number: EMA/578620/2015