EMEA-000281-PIP01-08-M02 - paediatric investigation plan

Recombinant human monoclonal antibody of the IgG1 class to insulin-like growth factor-1 receptor (RO4858696)

Key facts

• Active Substance:
  Recombinant human monoclonal antibody of the IgG1 class to insulin-like growth factor-1 receptor (RO4858696)
• Therapeutic area:
  Oncology
• Decision number:
  P/242/2009
• PIP number:
  EMEA-000281-PIP01-08-M02
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Ewing sarcoma family of tumours (including Ewing sarcoma of bone, peripheral primitive neuroectodermal tumour, extraskeletal Ewing sarcoma, and Askin tumour)
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Roche Registration Limited

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  02/12/2009

Decision

P/242/2009: EMEA decision of 2 December 2009 on the acceptance of a modification of an agreed Paediatric Investigation Plan for Recombinant human monoclonal antibody of the IgG1 class to insulin-like growth factor-1 rece...

AdoptedReference Number: EMEA/759533/2009