P/118/2010 - paediatric investigation plan

Chimeric antibody to mesothelin (MORAB-009)

Key facts

• Active Substance:
  Chimeric antibody to mesothelin (MORAB-009)
• Therapeutic area:
  Oncology
• Decision number:
  P/118/2010
• PIP number:
  P/118/2010
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Mesothelioma
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Eisai Ltd

  E-mail: [e-mail]; Country: United Kingdom; Phone: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/07/2010

Decision

P/118/2010: European Medicines Agency decision of 7 July 2010 on the granting of a product specific waiver for chimeric antibody to mesothelin (MORAB-009) (EMEA-000833-PIP01-10) in accordance with Regulation (EC) No 1901...

AdoptedReference Number: EMA/413738/2010