Reporting side effects

Pharmacovigilance has been defined by the World Health Organization as "science and activities related to discovery, evaluation, understanding and prevention of drug-related adverse events or any other drug-related problem".


Any unfavorable and unwanted event that occurs in a patient who has been given a medicinal product.


Reporting adverse events of medicinal products is important because it allows continuous monitoring of their benefit / risk balance. Healthcare personnel are required to report any adverse events associated with the use of medicinal products at the National Health Authority.


Any adverse event occurring in the course of or following therapy with a medicinal product should be promptly reported to the treating physician or pharmacist. If you can not contact them directly and you want to report an adverse event, you can do so by going to the website of the Italian Medicines Agency (AIFA) at the following link:

Anyone who wishes to report an adverse event with the use of our medicinal product may contact the Alfasigma Pharmacovigilance Office by calling the following number: 06 91393310
or by sending an email using the form below.


Contact your health care provider if you suspect you have had an adverse event with the use of medicinal products or consult the National Health Authority website. Anyone who wishes to report an adverse event with the use of our medicinal product may contact the Alfasigma Pharmacovigilance Office by calling the following number:
+39 06 91393360

Operation executed

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Spontaneous reporting - Information pursuant to art. 13 of Legislative Decree 196/2003
According to art. 13 of Legislative Decree no. 196/2003, Code on the Protection of Personal Data (hereinafter the "Privacy Code") Alfasigma S.p.A. (Hereinafter referred to as "Alfasigma") wishes to inform you about the processing of personal data that you freely provide through a spontaneous reporting under the pharmacovigilance system.

The personal data that you have provided will be collected and processed solely in connection with pharmacovigilance activity, which the Company is required by law. The provision of data is free, but their non-delivery may undermine correct reporting management.
The data will be collected and processed solely for the proper realization of related and instrumental activities for the purposes of pharmacovigilance, such as: (i) identification of any undesirable adverse reactions; (ii) improving and enhancing information on suspected adverse reactions already known; (iii) assessing the causal link between drug administration and observed adverse reaction; (iv) notify the competent authority of this information to ensure that the drugs used have a favorable benefit / risk profile for the population.

The processing of the personal data provided may be done by means of manual, computer and telematic tools, with logic strictly related to the purposes for which the data was collected and in any case suitable for ensuring the security and confidentiality of the data processed.
The data provided will be made available for the above purposes to subjects accessing the National Pharmacovigilance Network as well as to persons undergoing pharmacovigilance activities (AIFA, Marketing Authorization Holders, Italian Regions, Units Sanitary Spaces, Pharmacovigilance Office of Hospitals or Research and Care Institutes of Scientific Character). The personal data provided may also be communicated, for the above purposes, to the following categories of subjects: (i) persons, companies, associations providing legal aid, information and control services or consultancy services to the Companies Alfasigma; (ii) persons whose access to personal data is recognized by law and / or secondary legislation or by public authorities.
Subjects belonging to the aforementioned categories will use the data as autonomous holders and in relation to the specific activity performed or, in relation to the activity being performed, those responsible for the treatment appropriately named.
Personal data collected will be stored for the period of time required, in accordance with current regulations.
Where provided for by law, it is possible to exercise, by request to be sent to the Manager or the Holder, the rights referred to in art. 7 of the Privacy Code, as to obtain confirmation of the existence of your personal data; Have knowledge of the origin of the data as well as the logic and purpose of the Treatment; Obtain the identification of the categories of subjects to whom the data can be communicated or that they may be aware of.
The holder of the treatment is Alfasigma S.p.A. with legal headquarters in Viale Sarca, 223 - 20126 Milano and the administrative headquarters Via Ragazzi del '99, 5 - 40133 Bologna and can be contacted by sending an email to