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.
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.
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 or from occupational exposure. Conditions of use outside of marketing authorization include off-label use, overdose, misuse, abuse and medication errors.
Any untoward event that occurs following medical treatment must be promptly reported.
If you need to report an adverse drug reaction related to Chiesi drugs on territory of Bulgaria, we kindly request that you follow the instructions indicated in the link below instead of using the website or email:
If you need to contact the Chiesi directly during office hours you can:
Call
send an e-mail to
If you need to contact the Chiesi directly after office hours you can:
Call 
