Pharmacovigilance, as defined by the World Health Organization (WHO), is “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.”
Adverse Drug Reaction
An adverse reaction is a response to a medicinal product which is noxious and unintended. This includes adverse reactions which arise from:
- the use of a medicinal product within the terms of the marketing authorization
- the use outside the terms of the marketing authorization, including overdose, off-label use, misuse, abuse and medication errors
- occupational exposure.
How to, and to whom, report an adverse reaction
Contact the Competent Authority’s Pharmacovigilance Office.
If you wish to directly notify Kedrion about a suspected adverse reaction related to our drugs, please fill in the form below: