PASS TachoSil Evaluation (PasTel): Short- and long-term safety evaluation of TachoSil in paediatric population

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study

Study drug and medical condition

• Name of medicine:
  TACHOSIL
• Study drug International non-proprietary name (INN) or common name:
  HUMAN THROMBIN

  HUMAN FIBRINOGEN
• Anatomical Therapeutic Chemical (ATC) code:
  (B02BC30) combinations

  combinations

Population studied

• Short description of the study population:
  Infants and toddlers (>= 28 days - < 2 years) on the day of signing the ICF; Children (>=2 years – < 12 years) on the day of signing the ICF; Adolescents (>=12 years – less than 15 years) on the day of signing the ICF
• Age groups:
  • Paediatric Population (< 18 years)

    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)