Pharmacovigilance

Pharmacovigilance includes all the activities designed to evaluate the information associated to the safety of pharmaceutical products, and to ensure that a favourable benefit/risk ratio is maintained for all marketed medicinal products.

The Pharmacovigilance department of the Pharmaceutical Company is therefore responsible to collect and analyze any report of adverse events that may be associated with the use of a medicinal product, even if these are already known or already reported on the reference documents of the product (e.g. package leaflet). Potential drug associated adverse events includes also situations different from the drug use approved conditions.

The contribute of physicians, patients, nurses, or other health care professionals is essential for maintaining the drugs safety profile through the adverse events reporting. According to the current legislation, these information must be forwarded to the Responsible for Pharmacovigilance of the local health department.

To report a potential adverse event occurred after the use of an MDM medicinal product, please:
– fill in the appropriate form following the instructins at this link: www.aifa.gov.it/moduli-segnalazione-reazioni-avverse

– follow the Step-by-Step procedure on Vigifarmaco website www.vigifarmaco.it

– inform your physician or pharmacist, they will forward the report to the local health department

Alternatively, it is possible to directly inform the company about a possible adverse event associated to an MDM product at the following contact details.

MDM S.p.A. PHARMACOVIGILANCE CONTACTS

MDM has appointed the company Phast Consulting S.r.l. to manage its Pharmacovigilance activities and has appointed Dr. Stefano Maglie as MDM Pharmacovigilance Manager and EU QPPV. These are the contacts for any Pharmacovigilance reports:

Dr. Stefano Maglie (MDM Pharmacovigilance Manager and EU QPPV)
Dr.ssa Paola De Feudis (Deputy in the absence of Dr. Maglie)

Tel. 02.95109253 – Mobile 344 004 5982

Fax 039.3305126

email farmacovigilanza@mdmspa.com