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Agenzia Italiana del Farmaco
Ricerca AIFA
List of titles Safety of medicinal products
Hydroxyprogesterone caproate medicines to be suspended from the EU market Highlights News
EMA’s safety committee, PRAC, has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union (EU).
Fri May 17 00:00:00 CEST 2024 Safety of medicinal productsFondi di Farmacovigilanza Attiva: sancito in Conferenza Stato-Regioni l’Accordo per l’utilizzo dei fondi per gli anni 2018, 2019, 2020, 2021 e 2022 Highlights News
La Conferenza Permanente per i rapporti tra lo Stato, le Regioni e le Province Autonome di Trento e Bolzano ha sancito il 18 aprile 2024 l’Accordo per l’utilizzo dei Fondi di Farmacovigilanza Attiva relativi agli anni 2018, 2019, 2020, 2021 e 2022, pari complessivamente a € 58.500.000,00.
Mon May 13 00:00:00 CEST 2024 Safety of medicinal products > Fondi regionali di farmacovigilanzaMedicinal products containing RISPERIDONE, in oral solution formulation, and cases of accidental overdose following administration errors Highlights News
AIFA draws attention to the importance of administering the correct dose of medicines containing risperidone, in oral solution formulation, in children and adolescents.
Fri May 03 00:00:00 CEST 2024 Safety of medicinal productsEMA raccomanda l’aggiornamento della composizione antigenica dei vaccini anti-COVID-19 autorizzati per il periodo 2024-2025
La Task Force per le Emergenza (ETF) dell’EMA si è consultata con l’Organizzazione Mondiale della Sanità (OMS), regolatori internazionali e titolari di autorizzazioni all’immissione in commercio di vaccini anti- COVID-19, ed è del parere che l'aggiornamento della composizione antigenica dei vaccini per contrastare la famiglia JN.1 delle sottovarianti Omicron è adeguato per garantire la reattività crociata contro gli attuali ceppi virali dominanti ed emergenti.
Tue Apr 30 00:00:00 CEST 2024 Safety of medicinal productsMeeting highlights from PRAC 8-11 April 2024 Highlights News
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2024.
Fri Apr 12 00:00:00 CEST 2024 Safety of medicinal productsDirect communication with healthcare professionals on chiormadinone acetate/ethinylestradiol Highlights News
Combined hormonal contraceptive (CHC) – chiormadinone acetate/ethinylestradiol Slightly increased risk of venous thromboembolism in women using chlormadinone acetate and ethinylestradiol containing combined hormonal contraceptives.
Fri Mar 22 00:00:00 CET 2024 Safety of medicinal productsDirect communication with healthcare professionals on Paxlovid Highlights News
Paxlovid (nirmatrelvir; ritonavir): reminder of life-threatening and fatal drug-drug interactions with certain immunosuppressants, including tacrolimus.
Thu Mar 21 00:00:00 CET 2024 Safety of medicinal productsDirect communication with healthcare professionals on Oral Retinoids (acitretin, alitretinoin, and isotretinoin) Highlights News
Oral Retinoids (acitretin, alitretinoin, and isotretinoin): Reminder of restrictions to prevent exposure during pregnancy.
Wed Mar 13 00:00:00 CET 2024 Safety of medicinal productsMeeting highlights from PRAC 4-7 March 2024 Highlights News
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2024.
Fri Mar 08 00:00:00 CET 2024 Safety of medicinal productsDirect communication with healthcare professionals on etoposide-containing medicinal products Highlights News
Etoposide: Risk of infusion-related hypersensitivity reactions when administered with an in-line filter.
Mon Mar 04 00:00:00 CET 2024 Safety of medicinal productsDirect communication with healthcare professionals on medicines containing valproate Highlights News
Valproate containing medicines: new measures regarding the potential risk of neurodevelopmental disorders in children of fathers treated with valproate in the 3 months prior to conception.
Mon Feb 19 00:00:00 CET 2024 Safety of medicinal productsDirect communication with healthcare professionals on pseudoephedrine-containing medicines Highlights News
Few cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported with the use of pseudoephedrine-containing medicines.
Mon Feb 12 00:00:00 CET 2024 Safety of medicinal productsMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2024 Highlights News
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2024.
Fri Feb 09 00:00:00 CET 2024 Safety of medicinal productsPrecautionary measures to address potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines Highlights News
the CMDh endorsed precautionary measures recommended by PRAC for the treatment of male patients with valproate medicines.
Fri Jan 26 00:00:00 CET 2024 Safety of medicinal productsEMA confirms measures to minimise the risk of serious side effects with medicines containing pseudoephedrine Highlights News
EMA’s human medicines committee (CHMP) endorsed the measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) to minimise the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) for medicines containing pseudoephedrine.
Fri Jan 26 00:00:00 CET 2024 Safety of medicinal productsMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2024 Highlights News
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 January 2024.
Fri Jan 12 00:00:00 CET 2024 Safety of medicinal productsPotential risk of neurodevelopmental disorders in children born to men treated with valproate medicines: PRAC recommends precautionary measures Highlights News
EMA’s safety committee (PRAC) is recommending precautionary measures for the treatment of male patients with valproate medicines.
Fri Jan 12 00:00:00 CET 2024 Safety of medicinal productsMeeting highlights from PRAC 27-30 November 2023 Highlights News
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2023 with new safety information for GLP-1 receptor agonists.
Fri Dec 01 00:00:00 CET 2023 Safety of medicinal productsPRAC recommends measures to minimise the risk with medicines containing pseudoephedrine Highlights News
EMA’s safety committee, PRAC, has recommended new measures for medicines containing pseudoephedrine to minimise the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
Fri Dec 01 00:00:00 CET 2023 Safety of medicinal productsDirect communication with healthcare professionals on Atossisclerol Highlights News
AIFA calls to the correct use of the Atossisclerol medicine, in particular the foam formulation.
Wed Nov 29 00:00:00 CET 2023 Safety of medicinal productsDirect communication with healthcare professionals on Omega-3-acid ethyl ester medicines Highlights News
Omega-3-acid ethyl ester medicines: dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors.
Wed Nov 08 00:00:00 CET 2023 Safety of medicinal productsEMA recommends approval of adapted Nuvaxovid COVID-19 vaccine targeting Omicron XBB.1.5 Highlights News
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Nuvaxovid vaccine targeting the Omicron XBB.1.5 subvariant of the SARS-CoV-2 virus.
Wed Nov 08 00:00:00 CET 2023 Safety of medicinal productsTopiramate: new restrictions to prevent exposure during pregnancy Highlights News
DHPC in agreement with the European Medicines Agency (EMA) and AIFA to inform healthcare professionals of the implementation of a pregnancy prevention programme for topiramate-containing medicinal products.
Thu Nov 02 00:00:00 CET 2023 Safety of medicinal productsMeeting highlights from PRAC 23-26 October 2023 Highlights News
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2023.
Fri Oct 27 00:00:00 CEST 2023 Safety of medicinal productsEMA: New measures to avoid topiramate exposure in pregnancy Highlights News
the CMDh endorsed new measures recommended by PRAC in September to avoid exposure of children to topiramate-containing medicines in the womb.
Fri Oct 13 00:00:00 CEST 2023 Safety of medicinal products