• Pharmacovigilance

    Pharmacovigilance

    An important drug safety monitoring tool for healthcare professionals and citizens

What is an adverse reaction?

Drugs can trigger biological responses that vary from individual to individual. Therefore, adverse reactions (undesired effects associated with the use of drugs) cannot be identified during clinical development prior to placement on the market. For this reason, healthcare professionals and citizens are provided with a reporting tool to allow Sophos to update the safety information for the drugs it places on the market, thus fulfilling a precise legal obligation and helping to protect public health.

If you wish to contact us directly, please read the personal data processing disclosure carefully before sending, to the addresses below, any report or request for information.

I hereby declare having read the Informativa della Privacy and my wish to proceed.

How to report an adverse reaction

For patients

Every adverse reaction or undesired effect that occurs during or following pharmacotherapy must be promptly reported to the healthcare professional, the medical practitioner, or the pharmacist. A suspicious reaction can be reported in the following ways:
  • using the form available at the Agenzia Italiana del Farmaco (AIFA) website at the link to adverse reactions reporting forms, under “Data sheet for the citizen” (click here);

  • via the VigiFarmaco website for online reporting (click here).

For healthcare professionals

Healthcare personnel is required to report to Agenzia Italiana del Farmaco (AIFA) any adverse event associated with the use of drugs. Healthcare professionals can report a suspicious reaction in the following ways:
  • using the form available at the Agenzia Italiana del Farmaco (AIFA) website at the link to adverse reactions reporting forms, under “Data sheet for the healthcare professional” (click here);
  • via the VigiFarmaco website for online reporting (click here).

AIFA’s site offers constant pharmacovigilance updating (click here).

Sophos pharmacovigilance office contacts

Lucia Rocchi

Submit your report

Entra in contatto con
Sophos Biotech
Via Lima, 35 - 00198 Roma

Contact Sophos Biotech
Via Lima, 35 – 00198 ROME

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Area riservata

Reserved area

Area riservata a medici e farmacisti per visualizzare gli RCP dei prodotti.
Area reserved for physicians and pharmacists to view the summary of product characteristics (SPC).
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Sophos Biotech S.r.l. | P.IVA / CODICE FISCALE 13530751000 | Capitale sociale euro 100.000
Sophos Biotech S.r.l. | VAT / FISCAL CODE 13530751000 | Share capital 100,000 euros
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