EMEA-000800-PIP01-09-M01 - paediatric investigation plan

Ombrabulin

Key facts

• Active Substance:
  Ombrabulin
• Therapeutic area:
  Oncology
• Decision number:
  P/269/2011
• PIP number:
  EMEA-000800-PIP01-09-M01
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  • Treatment of non-rhabdomyosarcoma soft tissue sarcoma
  • Treatment of rhabdomyosarcoma
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Sanofi-aventis recherche & developpement

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/10/2011

Decision

P/269/2011: EMA decision of 28 October 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ombrabulin (EMEA- 000800-PIP01-09-M01)

AdoptedReference Number: EMA/847881/2011