Pharmacovigilance

PHARMACOVIGILANCE AND DRUGS SAFETY

ACS Dobfar S.p.A. is committed to ensuring the ongoing safety of its medicinal products through active pharmacovigilance. Pharmacovigilance encompasses a series of activities aimed at identifying, evaluating, understanding, and preventing adverse reactions, which are any unfavorable and unintended effects that occur following the administration of a drug. Ensuring this process is vital to maintaining high-quality standards and safeguarding patient well-being.

The safety reports can be transmitted by healthcare operators (physicians, nurses, pharmacists) and by the patients themselves both to the Competent Authorities and to the Marketing Company. The aim of the pharmacovigilance is the safety of patients.

 

Importance of Reporting Adverse Reactions

Reporting adverse drug reactions is crucial for informing healthcare providers, protecting patients, and ensuring a favorable benefit-risk balance for the population. This helps to continuously assess the safety profile of our medicines and adjust their use accordingly.

SAFETY DATA COLLECTION FORM

    REPORTER CONTACTS / CONTATTI DEL SEGNALATORE

    REPORTER QUALIFICATION* / QUALIFICA DEL SEGNALATORE*
    Patient / PazientePhysician / MedicoPharmacist / FarmacistaOther / Altro

    DRUG DETAILS / DETTAGLI SUL FARMACO

    MA/ANDA/NDA Holder / TITOLARE Autorizzazione all’Immissione in Commercio

    MEDICINAL PRODUCT NAME* / NOME DEL MEDICINALE*

    BATCH NUMBER / NUMERO DI LOTTO

    EVENT TO BE REPORTED / EVENTO DA SEGNALARE

    DATE OF REACTION / DATA DELLA REAZIONE

    ADVERSE REACTION or SAFETY INFORMATION DESCRIPTION* / DESCRIZIONE DELLA REAZIONE AVVERSA o INFORMAZIONI DI SICUREZZA*

    PATIENT’S INFORMATION / INFORMAZIONI del PAZIENTE

    Gender* / Genere*
    MFUnknown

    *mandatory field / campo mandatorio

    Receive copy of the transmitted module / Ricevere copia della segnalazione trasmessa

    AUTHORIZATION to be contacted by the MA/ANDA/NDA HOLDER for further information requests / AUTORIZZAZIONE ad essere contattati dal TITOLARE dell’Autorizzazione all’Immissione in Commercio

    PHARMACOVIGILANCE CONTACTS / CONTATTI FARMACOVIGILANZA

    +39 0290693570

    pharmacovigilance@acsdobfar.it