Active Substance’s EudraVigilance Substance Code. Source: EU Clinical Trials Register
An active substance (AS), is the substance in a medicinal product that is biologically active Source: EU Clinical Trials Register
A product that contains an active substance of biological or biotechnological origin Source: EU Clinical Trials Register
A product that contains an active substance of chemical origin Source: EU Clinical Trials Register
Subjects are aged 12 to less than 18 years. Source: EU Clinical Trials Register
Subjects are aged 18 to 64 years. Source: EU Clinical Trials Register
Advance Therapy Investigational Medicinal Products are medicinal products involving cell or gene therapy or tissue engineering. Source: EU Clinical Trials Register
Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Ref: DIRECTIVE 2001/20/EC Source: EU Clinical Trials Register
Anatomic, therapeutic, chemical. International system for classification of medicines maintained by World Health Organisation. Source: EU Clinical Trials Register
Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two preparations of a Medicinal Product. Source: EU Clinical Trials Register