What is Pharmacovigilance?
Pharmacovigilance has been defined by the World Health Organization as the science and activities related to the detection, evaluation, understanding and prevention of adverse effects or any other drug-related problems. ERREKAPPA EUROTHERAPIES, adhering to European legislation has its own pharmacovigilance system, which is a monitoring and reporting system used by the marketing authorization holder and member states to perform the functions and fulfill the responsibilities identified in this decree, aimed at monitoring the safety of authorized medicines and detecting any changes in their risk/benefit ratio (O.J. 143, 6/23/2015).
What is an adverse drug reaction?
An adverse reaction is defined as a harmful and unintended reaction resulting not only from the authorized use of a medicine under normal conditions of use but also from medication errors and uses that are not in accordance with the indications in the marketing authorization, including misuse and abuse of the medicine (O.J. 143 of 23-6-2015).
What to do in case of an adverse drug reaction?
You should consult your physician (providing all available details about the event and your medical history) before taking further action. If this is not possible, you could, in order to ensure that no report of a suspected adverse reaction to a drug marketed by ERREKAPPA EUROTERAPICI is missed, make such a report by clicking here.
Product quality and safety are a priority for ERREKAPPA EUROTERAPICI and are ensured at all levels by strict procedures for controlling and monitoring production processes, adhering to the requirements of European legislation and the guidelines of Good Manufacturing Practice (cGMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
Responsabile di Farmacovigilanza per reazioni avverse (QPPV)