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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 -  off-label use, overdose, misuse, abuse, medication errors and occupational exposure. Treatment during pregnancy and in breast feeding  mothers is also subject to reporting.


What is the Materiovigilance?

The Medical Device Vigilance (materiovigilance) is a system aimed at monitoring and evaluating incidents related to medical devices. The Medical Device Vigilance System aims to improve the protection of the health and safety of patients, healthcare professionals, and other users by reducing the likelihood of reoccurrence of incidents related to the use of a medical device.


What is an incident or an untoward event related to a medical device?

The term “incident” in the Medical Device Regulation (UE) 2017/745 means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect.


Information on how to report an adverse drug reaction or a medical device incident

Any untoward event that occurs following medical treatment or medical device usage must be reported.

If you need to report an adverse drug reaction related to Chiesi drugs or medical device incidents on territory of Slovakia, we are kindly asking you to report it to:


ŠUKL (State Institute for Drug Control, Kvetná 11, 825 08 Bratislava 26, Slovakia) by e-mail: neziaduce.ucinky@sukl.sk

or directly via the web portal for the message: https://portal.sukl.sk/eskadra/



Chiesi (reporting adverse reactions and / or complaints about product quality):
Tel. +421 2 593 000 60 (66)
Email: pharmacovigilance.sk (at) chiesi.com
At the end of the official hours, you can leave a link on the answering machine or call to +421 2 593 000 66.