EMEA-000833-PIP01-10 - 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:
  EMEA-000833-PIP01-10
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of mesothelioma
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/07/2010
• Compliance check done:
  No

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...

Adopted Reference Number: EMA/413738/2010