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

11/05/2021

Additional measures to allow experts to focus on COVID-19 activities

10/05/2021

Ondexxya (andexanet alfa): commercial anti-FXa activity assays are unsuitable for measuring anti-FXa activity following administration of andexanet alfa

10/05/2021

Ondexxya (andexanet alfa): Avoid use of andexanet prior to heparinization

07/05/2021

EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19

04/05/2021

EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated

03/05/2021

EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15

29/04/2021

EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen

26/04/2021

COVID-19 Vaccine Janssen: link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia

23/04/2021

AstraZeneca’s COVID-19 vaccine: benefits and risks in context

23/04/2021

Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from BioNTech/Pfizer and Moderna

23/04/2021

Benefits of ifosfamide solutions continue to outweigh risks

21/04/2021

COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets

15/04/2021

EMA starts review of VIR-7831 for treating patients with COVID-19

15/04/2021

EYLEA 40 mg/mL: Higher risk of intraocular pressure increase with the pre-filled syringe

15/04/2021

COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues

14/04/2021

AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets

13/04/2021

VAXZEVRIA/COVID-19 Vaccine AstraZeneca: link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia

09/04/2021

Direct Healthcare Professional Communication: EMOCLOT, KLOTT, PLASMACLOT, UMAN COMPLEX, KEDCOM, AIMAFIX, KEDRIFIX, IXED, ATKED, ATIII KEDRION

08/04/2021

AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets

01/04/2021

AstraZeneca COVID-19 vaccine: review of very rare cases of unusual blood clots continues

All news

— 20 Items per Page

Showing 1 - 20 of 1,626 results.

Uffici di riferimento

Reference offices

Post Marketing Surveillance Department

Anna Rosa Marra

ar.marra@aifa.gov.it

Site Map