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

01/12/2022

Direct communication with healthcare professionals on Terlipressin

11/11/2022

EMA raccomanda l’approvazione del vaccino VidPrevtyn Beta come richiamo per la vaccinazione COVID 19

11/11/2022

EMA confirms measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders

11/11/2022

New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome

11/11/2022

Direct communication with healthcare professionals on Spikevax bivalent booster vaccines

10/11/2022

Direct communication with healthcare professionals on Chlormadinone acetate and nomegestrol acetate

04/11/2022

Direct communication with healthcare professionals on Xalkori (crizotinib)

03/11/2022

Direct communication with healthcare professionals on Imbruvica (ibrutinib)

28/10/2022

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 – 27 October

28/10/2022

EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines

28/10/2022

EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders

20/10/2022

EMA recommends approval of second adapted Spikevax vaccine

20/10/2022

EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age

13/10/2022

Direct communication with healthcare professionals on NeoRecormon (epoetin beta)

04/10/2022

Direct communication with healthcare professionals on Natpar (parathyroid hormone)

30/09/2022

New recommendations for terlipressin-containing fmedicines in the treatment of hepatorenal syndrome

30/09/2022

Highlights della riunione del Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26 – 29 September

26/09/2022

Direct communication with healthcare professionals on NULOJIX (belatacept)

21/09/2022

EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines

21/09/2022

Synchron Research Service: re-examination confirms suspension of medicines over flawed studies

All news

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Uffici di riferimento

Reference offices

Post Marketing Surveillance Division

Anna Rosa Marra

ar.marra@aifa.gov.it

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