.png)
Agenzia Italiana del Farmaco
Ricerca AIFA
List of titles Comunicazioni AIFA/EMA
Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines Highlights News
Following an EU-wide review of available data on finasteride and dutasteride medicines, EMA’s safety committee, PRAC, has confirmed suicidal ideation (suicidal thoughts) as a side effect of finasteride 1 and 5 mg tablets.
Thu May 08 00:00:00 CEST 2025 Safety of medicinal productsEMA starts review of Ixchiq (live attenuated chikungunya vaccine)
MA’s safety committee (PRAC) has started a review of Ixchiq (a live attenuated chikungunya vaccine) following reports of serious adverse events in elderly people.
Thu May 08 00:00:00 CEST 2025 Safety of medicinal productsCommunication on the national management of Follow-UP questionnaires Highlights News
Following the publication by the European Medicines Agency (EMA) of the ‘Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)’, effective from 1 February 2025, the Italian Medicines Agency (AIFA) would like to provide clarification on the nature and management of the Specific AR FUQs.
Wed Apr 02 00:00:00 CEST 2025 Safety of medicinal productsEMA concludes review of weight management medicine Mysimba Highlights News
EMA’s human medicines committee (CHMP) has finalised its review of Mysimba (naltrexone / bupropion), a medicine used for weight management in adults, concerning the potential long-term cardiovascular risk.
Fri Mar 28 00:00:00 CET 2025 Safety of medicinal productsUnregulated advanced therapy medicinal products pose serious risks to health Highlights News
EMA and the Heads of Medicines Agencies (HMA) are warning the public about the dangers of unregulated advanced therapy medicinal products (ATMPs) offered to patients in the European Union.
Thu Mar 13 00:00:00 CET 2025 Safety of medicinal productsUpdated advice to minimise risks of interaction between weight loss medicine Mysimba and opioids Highlights News
After re-examining its initial opinion, EMA recommends updating the advice aimed at minimising the risks of interaction between the weight loss medicine Mysimba (naltrexone/bupropion) and opioid-containing medicines.
Fri Nov 15 00:00:00 CET 2024 Safety of medicinal productsEMA starts safety review of medicines containing finasteride and dutasteride Highlights News
During the review, PRAC will assess all available data linking finasteride and dutasteride to suicidal ideation and behaviours.
Fri Oct 04 00:00:00 CEST 2024 Safety of medicinal productsEMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole Highlights News
EMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole.
Fri Sep 20 00:00:00 CEST 2024 Safety of medicinal productsEMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole Highlights News
Product information to be updated to raise awareness of known risk of agranulocytosis and facilitate its early detection and diagnosis.
Mon Sep 09 00:00:00 CEST 2024 Safety of medicinal productsEMA advises about risks of using weight loss medicine Mysimba with opioids Highlights News
Use of opioid medicines with Mysimba may lead to serious side effects.
Mon Jul 29 00:00:00 CEST 2024 Safety of medicinal productsEMA conferma la raccomandazione di non rinnovare l'autorizzazione all'immissione in commercio di Ocaliva Highlights News
Il Comitato per i medicinali per uso umano (CHMP) dell'EMA ha concluso la revisione del medicinale Ocaliva (acido obeticolico) e ha raccomandato che l'autorizzazione all'immissione in commercio del medicinale sia revocata, poiché i benefici non sono più considerati superiori ai rischi.
Tue Jul 09 00:00:00 CEST 2024 Access to medicinal products > Authorisation of medicinal productsEMA communication on hydroxyprogesterone caproate medicines Highlights News
Review of studies raises possible safety concern and finds no effect in preventing premature birth.
Fri Jun 28 00:00:00 CEST 2024 Safety of medicinal productsReview of painkiller metamizole started Highlights News
Review will look into risk of agranulocytosis, a sudden drop in white blood cells that can lead to serious infections, and measures to minimise it.
Fri Jun 14 00:00:00 CEST 2024 Safety of medicinal productsHydroxyprogesterone 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 productsMedicinal 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 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 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 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 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 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 productsSpikevax: EMA recommends approval of adapted COVID 19 vaccine targeting Omicron XBB.1.5 Highlights News
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax vaccine targeting the Omicron XBB.1.5 subvariant.
Mon Sep 18 00:00:00 CEST 2023 Safety of medicinal productsPRAC recommends new measures to avoid topiramate exposure in pregnancy Highlights News
EMA’s safety committee (PRAC) recommends new measures to avoid exposure of children to topiramate-containing medicines in the womb.
Fri Sep 01 00:00:00 CEST 2023 Safety of medicinal productsComirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5 Highlights News
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Comirnaty vaccine targeting the Omicron XBB.1.5 subvariant.
Wed Aug 30 00:00:00 CEST 2023 Safety of medicinal products