Pharmacovigilance

Chiesi Spain has a Pharmacovigilance System in order to assume liability for our medicinal products and to take appropriate actions when necessary to assure their safety profile. We ensure that all information relevant to the benefit-risk ratio of our medicinal products is continuously evaluated. When important safety issues arise, if applicable, we promptly notify to Concerned Health Authorities, Healthcare Professionals and patients in accordance with current legislation.

What is Pharmacovigilance?

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem (Ref. World Health Organization (WHO). The importance of pharmacovigilance: safety monitoring of medicinal products, Genève, WHO, 2002).

In line with this general definition general, the main objectives of Pharmacovigilance in accordance with the applicable EU legislation are:

• Preventing harm from adverse reactions s in humans;
• Promoting the safe and effective use of medicinal products, in particular by providing timely information about the safety of medicinal products for patients, healthcare professionals and the general 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 use of the product within or outside the terms of the marketing authorization or from occupational exposure.

Conditions of use outside the marketing authorization include: off-label use, overdose, misuse, abuse and medication errors.

Information on how to report adverse drug reactions

Any untoward event that occurs following medical treatment must be promptly reported either to the family doctor or to the pharmacist.

If you need to report an adverse drug reaction related to Chiesi drugs, we kindly request to contact with:

farmacovigilancia@chiesi.com

Tel. 0034 93 494 80 00

You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicinal Products: https://www.notificaram.es