Pharmacovigilance

Reporting of suspected drug adverse reactions

The spontaneous reporting of suspected drug adverse reactions represents an important source of information for pharmacovigilance activities, as it allows to detect potential safety signals about the use of all the drugs available on the market. Pharmacovigilance involves patients, prescribing doctors, healthcare professionals, pharmaceutical companies, institutions and universities; not only healthcare professionals can report suspected adverse reactions, but also citizens.

HOW TO REPORT A SUSPECTED ADVERSE REACTION

Every country has specific laws governing the reporting of adverse drug reactions, therefore if you experience adverse drug reactions with Ecupharma medicinal products authorised in a specific country, you are asked to report the suspected drug adverse reaction according to the local legislation or directly to Ecupharma (see below).

If you are taking an Ecupharma’s medicinal product authorised in Italy

To report a suspected adverse reaction occurring after the use of an Ecupharma’s medicinal product authorised in Italy, one of the following methods can be applied:

1. Fill the dedicated report sheet available on the link https://www.aifa.gov.it/en/content/segnalazioni-reazioni-avverse and forward it by e-mail or fax to the Responsible for Pharmacovigilance of the competent Local Health Authority (ASL) to the addresses reported in the following web site: https://www.aifa.gov.it/en/responsabili-farmacovigilanza
   
   
2. Online on the AIFA website (as healthcare professionals and citizens), report an adverse reaction (ADR): https://servizionline.aifa.gov.it/schedasegnalazioni/
   
   
3. Reports can be forwarded directly to Ecupharma. To contact the Ecupharma pharmacovigilance team, please fill in the form down below 
   
   
4. Alternatively, suspected adverse drug reactions can be reported to the Company by the following link: Segnalazioni di farmacovigilanza (direnzo.biz).
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