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Pharmacovigilance

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:

  • preventing harm from adverse reactions in humans;
  • promoting the safe and effective use of medicinal products, in particular by providing timely information on the safety of medicinal products for patients, healthcare professionals and the public.

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 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
+359 2 920 12 05
+359 2 829 81 73
   send an e-mail to 


If you need to contact the Chiesi directly after office hours you can:

 

   Call 
+359 885 150 578