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

02/10/2023

Meeting highlights from PRAC 25-28 September 2023

20/09/2023

Fluoroquinolone antibiotics – AIFA survey to evaluate the impact of information initiatives on healthcare professionals

18/09/2023

Spikevax: EMA recommends approval of adapted COVID 19 vaccine targeting Omicron XBB.1.5

04/09/2023

Direct communication with healthcare professionals on Voxzogo®️ (vosoritide)

01/09/2023

PRAC recommends new measures to avoid topiramate exposure in pregnancy

30/08/2023

Comirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5

17/08/2023

EMA review of data on paternal exposure to valproate

09/08/2023

Direct communication with healthcare professionals on Simponi (golimumab)

07/08/2023

EMA review data on the risk of neurodevelopmental disorders following paternal exposure to valproate in the months preceding conception

12/07/2023

EMA statement on ongoing review of GLP-1 receptor agonists

05/07/2023

Modification of the indications and the authorised population of medicinal products containing salbutamol and ipratropium bromide in fixed-dose combination (FDC)

16/06/2023

Direct communication with healthcare professionals on GAVRETO (pralsetinib)

15/06/2023

Direct communication with healthcare professionals on ADAKVEO (crizanlizumab)

08/06/2023

Direct communication with healthcare professionals on systemic and inhaled fluoroquinolone antibiotics

16/05/2023

Meeting highlights from PRAC 10-12 May 2023

12/05/2023

EMA: review of hydroxyprogesterone started

12/05/2023

Fluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting, disabling and potentially irreversible side effects

04/04/2023

EMA recommends approval of Bimervax as a COVID-19 booster vaccine

31/03/2023

Direct communication with healthcare professionals on Minirin/DDAVP (desmopressin)

16/03/2023

Direct communication with healthcare professionals on Janus kinase inhibitors (JAKi)

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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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