Chiesi has a system of pharmacovigilance to assume liability for our medicinal products (whether marketed or under clinical development) and to take appropriate action when necessary. We ensure that all information relevant to the benefit-risk ratio of our medicines is continually evaluated. When important safety issues arise, if applicable, we promptly notify healthcare to affected professionals, patients and regulatory agencies in accordance with current legislation.
What is Pharmacovigilance?
Pharmacovigilance is the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other medical-related problem (WHO, Geneva, WHO, 2002).
In line with this general definition, the main objectives of pharmacovigilance in accordance with the applicable EU legislation are:
Pharmacovigilance is therefore an activity contributing to the protection of patient and public health.
What is an Adverse Drug Reaction?
A response to a medicinal product which is harmful and unintended (response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility).
Adverse reactions may arise from the use of the product within or outside the terms of marketing authorization - off-label use, overdose, misuse, abuse, medication errors and occupational exposure. Treatment during pregnancy and in breast feeding mothers is also subject to reporting.
Any untoward event that occurs following medical treatment must be reported.
If you need to report an adverse drug reaction related to Chiesi drugs on territory of Slovakia, we are kindly ask you to report it to:
or directly via the web portal for the message: https://portal.sukl.sk/eskadra/