Chiesi France SAS has a system of pharmacovigilance in order to assume liability for our medicinal products (whether marketed or under clinical development) and to take appropriate actions when necessary. 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 healthcare the professionals, patients and regulatory agencies concerned 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, the main objectives of pharmacovigilance in accordance with the applicable EU legislation are:

• preventing risks from adverse reactions 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 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 authorisation or from occupational exposure. Conditions of use outside the marketing authorisation include off-label use, overdose, misuse, abuse and medication errors.

Information on how to report adverse drug reactions

If you are in France

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

If you want to report an adverse drug reaction related to Chiesi drugs, you can report it to your Regional Drug Safety Center by following the instructions indicated in the link below:

  French Government Website - Report an adverse event 

OR contact the Chiesi pharmacovigilance department directly:

As part of the report of an adverse event occurred on a Chiesi S.A.S. proprietary medicine, you will be asked to transmit personal data by phone, fax or email.
The processing of your information has been declared to the CNIL for managing health data collected in the context of the post-marketing authorization pharmacovigilance of medicinal products.
The recipients of your information are CHIESI authorized departments or, if applicable, its subcontractors.
In accordance with the amended Data Protection Act of January 06, 1978, you have a right of access, rectification, opposition and suppression of the collected data about you. You may exercise your rights with the CHIESI SAS head pharmacist by e-mail at the following address: infofrance@chiesi.com or by phone at +33 1 47 68 88 99.