EMEA-002766-PIP01-20 - paediatric investigation plan

recombinant human IgGlA monoclonal Fab antibody

Key facts

• Active substance:
  recombinant human IgGlA monoclonal Fab antibody
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0262/2020
• PIP number:
  EMEA-002766-PIP01-20
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Reversal of antiplatelet effects of ticagrelor in patients with uncontrolled major or life-threatening bleeding or requiring urgent surgery or invasive procedure
• Route(s) of administration:
  Intravenous use
• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  15/07/2020
• Compliance check done:
  No

Decision

P/0262/2020: EMA decision of 15 July 2020 on the refusal of a product specific waiver for recombinant human IgG1λ monoclonal Fab antibody (EMEA-002766-PIP01-20)

Adopted Reference Number: EMA/366113/2020