EMEA-000555-PIP01-09-M06 - paediatric investigation plan

decitabine

Key facts

• Invented name:
  • Dacogen
  • Dacogen
• Active Substance:
  decitabine
• Therapeutic area:
  Oncology
• Decision number:
  P/0234/2017
• PIP number:
  EMEA-000555-PIP01-09-M06
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  Treatment of acute myeloid leukaemia
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Janssen-Cilag International NV

  Ireland; Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/08/2017
• Compliance procedure number:
  EMEA-C-000555-PIP01-09-M06
• Compliance opinion date:
  18/10/2019
• Compliance outcome:
  Positive

Decision

P/0234/2017: EMA decision of 9 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for decitabine (Dacogen), (EMEA-000555-PIP01-09-M06)

AdoptedReference Number: EMA/434829/2017