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Agenzia Italiana del Farmaco
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EMA 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 productsEstensione automatica della scadenza dei certificati GMP
Si comunica che la validità di tutti i certificati GMP già scaduti o in scadenza è automaticamente estesa fino al 31/12/2024.
Wed Dec 13 00:00:00 CET 2023 Quality and Inspections > Inspections and authorisationsEMA 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 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 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 productsChaos and pandemic: a study on the evolution of emerging coronaviruses in PLOS ONE. Palù: “it will help public health in controlling future pandemic emergencies” Highlights News
A new study entitled "The chaos law is a principal driver of natural selection: A proposition on the evolution of recently emerged coronaviruses" has been published in the scientific journal PLOS ONE.
Mon Aug 28 00:00:00 CEST 2023 Information and communicationAntivirals and monoclonal antibodies for COVID-19: the AIFA monitoring summary report is online Highlights News
Il documento riepiloga i dati dei Registri e le attività condotte durante la pandemia.
Fri Jul 28 00:00:00 CEST 2023 Pricing and reimbursement > Monitoring RegistersMonitoring of monoclonal antibodies for COVID-19: weekly report published Highlights News
AIFA publishes the results of the monitoring related to monoclonal antibodies for the treatment of COVID-19 currently available.
Fri Jul 14 00:00:00 CEST 2023 Pricing and reimbursement > Monitoring RegistersMonitoring of antivirals for COVID-19: new report published Highlights News
The Italian Medicines Agency (AIFA) has published the results of the monitoring of antivirals currently available for treating COVID-19.
Fri Jul 14 00:00:00 CEST 2023 Pricing and reimbursement > Monitoring RegistersMonitoring of antivirals for COVID-19: new report published Highlights News
The Italian Medicines Agency (AIFA) has published the results of the monitoring of antivirals currently available for treating COVID-19.
Fri Jun 09 00:00:00 CEST 2023 Pricing and reimbursement > Monitoring RegistersMonitoring of monoclonal antibodies for COVID-19: weekly report published Highlights News
AIFA publishes the results of the monitoring related to monoclonal antibodies for the treatment of COVID-19 currently available.
Fri Jun 09 00:00:00 CEST 2023 Pricing and reimbursement > Monitoring RegistersMonitoring of monoclonal antibodies for COVID-19: weekly report published Highlights News
AIFA publishes the results of the monitoring related to monoclonal antibodies for the treatment of COVID-19 currently available.
Fri May 19 00:00:00 CEST 2023 Pricing and reimbursement > Monitoring RegistersMonitoring of antivirals for COVID-19: new report published Highlights News
The Italian Medicines Agency (AIFA) has published the results of the monitoring of antivirals currently available for treating COVID-19.
Fri May 19 00:00:00 CEST 2023 Pricing and reimbursement > Monitoring RegistersMonitoring of antivirals for COVID-19: new report published Highlights News
The Italian Medicines Agency (AIFA) has published the results of the monitoring of antivirals currently available for treating COVID-19.
Fri May 05 00:00:00 CEST 2023 Pricing and reimbursement > Monitoring RegistersMonitoring of monoclonal antibodies for COVID-19: weekly report published Highlights News
AIFA publishes the results of the monitoring related to monoclonal antibodies for the treatment of COVID-19 currently available.
Thu May 04 00:00:00 CEST 2023 Pricing and reimbursement > Monitoring RegistersMonitoring of monoclonal antibodies for COVID-19: weekly report published Highlights News
AIFA publishes the results of the monitoring related to monoclonal antibodies for the treatment of COVID-19 currently available.
Fri Apr 14 00:00:00 CEST 2023 Pricing and reimbursement > Monitoring RegistersMonitoring of antivirals for COVID-19: new report published Highlights News
The Italian Medicines Agency (AIFA) has published the results of the monitoring of antivirals currently available for treating COVID-19.
Thu Apr 13 00:00:00 CEST 2023 Pricing and reimbursement > Monitoring RegistersEMA recommends approval of Bimervax as a COVID-19 booster vaccine Highlights News
EMA’s human medicines committee (CHMP) has recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in people aged 16 years and above who have been vaccinated with an mRNA COVID-19 vaccine.
Tue Apr 04 00:00:00 CEST 2023 Safety of medicinal productsMonitoring of antivirals for COVID-19: new report published Highlights News
The Italian Medicines Agency (AIFA) has published the results of the monitoring of antivirals currently available for treating COVID-19.
Tue Mar 28 00:00:00 CEST 2023 Pricing and reimbursement > Monitoring RegistersMonitoring of monoclonal antibodies for COVID-19: weekly report published Highlights News
AIFA publishes the results of the monitoring related to monoclonal antibodies for the treatment of COVID-19 currently available.
Thu Mar 23 00:00:00 CET 2023 Pricing and reimbursement > Monitoring RegistersModifica Registro ANTIVIRALI ORALI COVID-19
Si informano gli utenti dei Registri dei farmaci sottoposti a Monitoraggio che, a partire dal 15/03/2023 non sarà più possibile utilizzare il medicinale Lagevrio (molnupiravir) all’interno del Registro ANTIVIRALI ORALI (COVID-19) dedicato al monitoraggio di una specifica indicazione terapeutica.
Wed Mar 15 00:00:00 CET 2023 Pricing and reimbursement > Monitoring RegistersMonitoring of antivirals for COVID-19: new report published Highlights News
The Italian Medicines Agency (AIFA) has published the results of the monitoring of antivirals currently available for treating COVID-19.
Fri Mar 10 00:00:00 CET 2023 Pricing and reimbursement > Monitoring RegistersMonitoring of monoclonal antibodies for COVID-19: weekly report published Highlights News
AIFA publishes the results of the monitoring related to monoclonal antibodies for the treatment of COVID-19 currently available.
Thu Mar 09 00:00:00 CET 2023 Pricing and reimbursement > Monitoring RegistersFourteenth AIFA Report on the surveillance of anti-COVID-19 vaccines Highlights News
The data collected and analysed concern the reports of suspected adverse reactions registered in the National Pharmacovigilance Network between 27 December 2020 and 26 December 2022.
Thu Mar 02 00:00:00 CET 2023 COVID-19 emergency > Vaccini COVID-19Monitoring of antivirals for COVID-19: new report published Highlights News
The Italian Medicines Agency (AIFA) has published the results of the monitoring of antivirals currently available for treating COVID-19.
Fri Feb 24 00:00:00 CET 2023 Pricing and reimbursement > Monitoring Registers