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:
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.
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