Identification, assessment and prevention

Pharmacovigilance is a public health activity focus on the identification, assessment and prevention of adverse reactions for marketed drugs. An Adverse Reaction is defined as any undesirable effect which appears after the administration of a drug.

In order to achieve this goal, a close collaboration is required among the different parts involved in the use of the medicine (pharmaceutical companies, health professionals, health authorities and patients). In this way, and faithful to our commitment for improving health and quality of life of patients and ensure their safety, CHEMO (Chemo Ibérica SA, Laboratorios Farmalán SA, Laboratorios León Farma SA, Laboratorios Liconsa SA, Universal Farma SL), EXELTIS, MABXIENCE in compliance with current legislation, provides a system for reporting Adverse Drug Reactions, in order to ensure drug safety and to inform to the relevant health authorities and take appropriate measures.


Insud Pharma, S.L.U., and aforementioned entities all belonging to Insud Pharma group (hereinafter, “Insud Pharma Group”), informs you that your personal data will be processed, stored and kept confidential in compliance with the privacy policies implemented by Insud Pharma Group and in accordance with the General (EU 2016/679) Data Protection Regulation. This data processing is legitimized by your consent when communicating us your information and reporting any adverse drug reactions, as well as based on the compliance of our legal pharmacovigilance obligations.

Personal data provided will be processed for pharmacovigilance purposes, as well as to solve any issue or query you may raise. If necessary, your personal data may be shared, prior anonymized, with the competent health authorities, companies which hold a marketing authorization of the product and other entities of Insud Pharma Group for the above-mentioned purposes. You could exercise your right of access, rectification, erasure, restriction of the processing, portability and objection, and contact our Data Protection Officer through