Safety of medicinal products

AIFA monitors the safe use of medicinal products to ensure the benefit/risk profile of each medicine is positive. Such activity is carried out through the continuous monitoring and evualuation of safety information and, where necessary, through the adoption of regulatory actions in order to promptly protect public health.

AIFA also ensures independent and timely information on the safety of medicinal products by encouraging patients and healthcare professionals to report suspected adverse reactions.

In addition, it promotes active pharmacovigilance programs and studies, in agreement with Regions and according to training and research plans with general practicioners, free choice pediatrician, scientific societies and universities.

News on safety

27/03/2026

Levamisole: the PRAC recommendation for withdrawal from the EU market has been confirmed

20/03/2026

Direct Healthcare Professional Communication (DHPC) on Remsima (infliximab)

13/03/2026

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March 2026

13/02/2026

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 February 2026

19/12/2025

Direct Healthcare Professional Communication (DHPC) on Carbamazepine (Tegretol 100 mg/5ml Oral Suspension)

11/12/2025

Direct Healthcare Professional Communication (DHPC) on tranexamic acid intravenous formulations

01/12/2025

Direct Healthcare Professional Communication (DHPC) on Rybelsus (oral semaglutide)

03/11/2025

Direct Healthcare Professional Communication (DHPC) on Levetiracetam (Keppra and Levetiracetam UCB)

31/10/2025

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 October 2025

15/10/2025

Direct Healthcare Professional Communication (DHPC) on Nifedicor

09/10/2025

Direct Healthcare Professional Communication (DHPC) on Crysvita (burosumab)

09/10/2025

Direct Healthcare Professional Communication (DHPC) on Caspofungin

16/09/2025

Direct Healthcare Professional Communication (DHPC) - Finasteride, dutasteride - New measures to minimise the risk of suicidal ideation

08/09/2025

Direct Healthcare Professional Communication (DHPC) - Clozapine and risk of neutropenia and agranulocytosis: PRAC updates recommendations for blood count monitoring

05/09/2025

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4 September 2025

16/07/2025

Direct communication with healthcare professionals on risperidone-containing medicines

11/07/2025

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 July 2025

06/06/2025

Important update from the PRAC about Ozempic, Rybelsus and Wegovy (semaglutide)

06/06/2025

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 june 2025

29/05/2025

Direct communication with healthcare professionals on Mysimba (naltrexone/bupropione)