EMEA-003178-PIP01-21 - paediatric investigation plan

Anti-TGFbeta fully human monoclonal antibody (NIS793)

Key facts

• Active Substance:
  Anti-TGFbeta fully human monoclonal antibody (NIS793)
• Therapeutic area:
  Oncology
• Decision number:
  P/0207/2022
• PIP number:
  EMEA-003178-PIP01-21
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of pancreatic cancer
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/06/2022

Decision

P/0207/2022: EMA decision of 10 June 2022 on the granting of a product specific waiver for anti-TGFbeta fully human monoclonal antibody (NIS793) (EMEA-003178-PIP01-21)

AdoptedReference Number: EMA/275703/2022