Chiesi pharmaceuticals GmbH 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 harm 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.

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.

Report of adverse drug reaction/medical device incident/product defects

Tel.    +43 / (0)1 / 407 39 19 - 0

Fax    +43 / (0)1 / 407 39 19 - 99018

Email: medinfo.at@chiesi.com

After office hours please call our hotline: Tel. + 43 / (0)676 / 88 555 518

All information and personal data that you share with us in case of a spontaneous reporting regarding a suspected adverse reaction (e.g. via phone, email...) will be protected and treated confidentially in accordance with company policies and local data protection regulations, including the EU General Data Protection Regulation 2016/679. Please note that Chiesi Pharmaceuticals GmbH will process your personal data as Data Controller. The information you provide will be processed for the purpose of monitoring drug safety and may be shared with health authorities or involved third parties. You have a right of access to the personal data we hold about you and may also exercise other data subject rights (e.g. the right to rectify, limit or erase your personal data, as applicable). For more information, please refer to the Privacy Notice at Privacy Notice Austria.