EMEA-002797-PIP01-20 - paediatric investigation plan

Oportuzumab monatox

Key facts

• Active Substance:
  Oportuzumab monatox
• Therapeutic area:
  Oncology
• Decision number:
  P/0287/2020
• PIP number:
  EMEA-002797-PIP01-20
• Pharmaceutical form(s):
  Intravesical solution
• Condition(s) / indication(s):
  Treatment of urothelial carcinoma
• Route(s) of administration:
  Intravesical use
• Contact for public enquiries:

  Sesen Bio, Inc

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/08/2020

Decision

P/0287/2020 : EMA decision of 12 August 2020 on the granting of a product specific waiver for oportuzumab monatox (EMEA-002797-PIP01-20)

AdoptedReference Number: EMA/377776/2020