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

12/01/2021

EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca

08/01/2021

Extra dose from vials of Comirnaty COVID-19 vaccine

06/01/2021

EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU

31/12/2020

Update on rolling review of AstraZeneca’s COVID-19 vaccine

30/12/2020

Updated on risk of respiratory depression and sedation associated with Epaclob 1mg/ml and 2mg/ml oral suspension® (clobazam)

23/12/2020

Kaletra (lopinavir/ritonavir) oral solution, 2 bottle pack containing 2-ml oral dosing syringes: Presence of amide particles in 2-ml oral dosing syringes

23/12/2020

Global recall: Zerbaxa (ceftolozane / tazobactam) 1 g/0.5 g powder for concentrate for solution for infusion

22/12/2020

NUBRIVEO (brivaracetam 10mg/ml) oral solution: bottles with narrow neck diameter

21/12/2020

EMA recommends first COVID-19 vaccine for authorisation in the EU

18/12/2020

Update on assessment of marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccine

17/12/2020

Risk of respiratory depression and sedation associated with Epaclob 1mg/ml and 2mg/ml oral suspension (clobazam)

15/12/2020

Metamizole: Risk of drug-induced liver injury

15/12/2020

Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application

09/12/2020

New formulation of suxamethonium chloride and impact on the actual amount of administered medicine

01/12/2020

Important information on Gliolan (5-aminolevulinic acid, 5-ALA)

01/12/2020

EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine

01/12/2020

EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2

01/12/2020

EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S

27/11/2020

Italian Medicines Agency's Communiction to CRFV / RLFV on the management of reporting adverse reactions to medicines used in COVID-19 therapy - UPDATE

23/11/2020

Update on remdesivir - EMA will evaluate new data from Solidarity trial

All news

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Uffici di riferimento

Reference offices

Post Marketing Surveillance Department

Anna Rosa Marra

ar.marra@aifa.gov.it

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