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Agenzia Italiana del Farmaco
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List of titles Highlights
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 productsItalian Medicines Agency's online services will be unavailable due to scheduled maintenance Highlights News
AIFA's online services will be undergoing scheduled maintenance from 1:30 to 2:00 p.m. on 16 May 2024.
Thu May 16 00:00:00 CEST 2024 The AgencyAIFA updates the Transparency Lists Highlights News
AIFA has published the updated Transparency Lists of generic medicines together with the related reference prices, updated at 15 May 2024.
Wed May 15 00:00:00 CEST 2024 Pricing and reimbursement > Transparency ListsPubblicata la Relazione annuale 2023 dell’Area Autorizzazioni Medicinali Highlights News
La Relazione annuale dell’Area Autorizzazioni Medicinali ha lo scopo di fornire un’informazione trasparente sulle attività di competenza dell’Area e degli Uffici afferenti svolte nel 2023.
Tue May 14 00:00:00 CEST 2024 Access to medicinal products > Authorisation of medicinal productsInformazione in merito al medicinale Translarna (ataluren) Highlights News
La Commissione Europea non ha ancora emanato la decisione finale. Pertanto, il Translarna deve considerarsi a tutti gli effetti autorizzato e prescrivibile ai pazienti.
Tue May 14 00:00:00 CEST 2024 Access to medicinal products > Authorisation of medicinal products“Horizon Scanning: scenario of upcoming medicines”. AIFA publishes Report 2024 Highlights News
The Report aims to provide information on new medicines and new extensions of therapeutic indications that have received a positive opinion from the EMA or may receive one in the coming years.
Mon May 13 00:00:00 CEST 2024 Information and communication > PublicationsGlyptins (antidiabetic drugs), first medicines reclassified from A-PHT Class to A Class Highlights News
The resolution was published in the Official Gazette of 10 May 2024.
Mon May 13 00:00:00 CEST 2024 Access to 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 farmacovigilanzaAggiornate le Q&A sui procedimenti di autorizzazione e registrazione per la produzione/importazione delle sostanze attive Highlights News
Il documento sostituisce il precedente pubblicato a ottobre 2023.
Fri May 10 00:00:00 CEST 2024 Inspections and authorisations > Ispezioni su fabbricazione materie primeBiosimilar medicines in Italy: AIFA reports updated Highlights News
The analyses of consumption and expenditure trends and regional variability are online.
Wed May 08 00:00:00 CEST 2024 Consumption and pharmaceutical expenditure > Monitoring pharmaceutical expenditureHepatitis C: update of 6 May 2024 concerning enrolled patients Highlights News
AIFA has published the updated weekly data concerning treatments with new second-generation direct acting antiviral agents (DAAs) for chronic hepatitis C, as collected by AIFA Monitoring registries.
Wed May 08 00:00:00 CEST 2024 Pricing and reimbursement > Monitoring RegistersScientific development of data from AIFA monitoring registries Highlights News
Data from the Italian Medicines Agency's Monitoring Registries on various oncological drugs were analysed in a study entitled "Comparison of baseline characteristics of patients in Italian monitoring registries of oncological drugs and registrative clinical trials: a cross-sectional real-world study", published in the journal The Lancet Regional Health - Europe.
Mon May 06 00:00:00 CEST 2024 Pricing and reimbursement > Monitoring RegistersMedicinal 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 productsInformation on the availability of Fluorouracil-based medicines Highlights News
AIFA wishes to provide information relating to the availability of Fluorouracil-based medicines on the Italian market.
Thu May 02 00:00:00 CEST 2024 Access to medicinal productsList of class A and H medicinal products at 15 November 2023 Highlights News
AIFA makes available, to healthcare professionals, a list of class A and H medicinal products dispensed by the National Health Service, sorted by active ingredient and trade name.
Mon Apr 29 00:00:00 CEST 2024 Pricing and reimbursement > Lists of Class A and Class H medicinal productsMonitoring of Pharmaceutical expenditure (January / November 2023) Highlights News
AIFA has published the documents relating to the monthly monitoring of national and regional pharmaceutical expenditure for the periods January / November 2023.
Wed Apr 24 00:00:00 CEST 2024 Consumption and pharmaceutical expenditure > Monitoring pharmaceutical expenditureAuthorisation of Conferences and Meetings Highlights News
We inform you that the timing initially foreseen for the validation of the request for conferences and meetings, referred to in Article 124 of Legislative Decree 219/2006, has been increased from 70 to 90 days from the date of the start of the event.
Tue Apr 23 00:00:00 CEST 2024 Companies SectionProcedure for the review and validation of lists of medicines whose property has been transferred from a pharmaceutical company to another Highlights News
The list of products for which a change of ownership occurred during 2023 is available exclusively for pharmaceutical companies that have transferred/acquired these pharmaceutical products.
Mon Apr 22 00:00:00 CEST 2024 Consumption and pharmaceutical expenditureProcedure for the review and validation of lists of therapeutic indications for innovative medicines by pharmaceutical companies Highlights News
The list of medicines that were recognised as innovative in 2023 has been made available only for marketing authorisation holders of medicines with full innovativeness status.
Mon Apr 22 00:00:00 CEST 2024 Consumption and pharmaceutical expenditureChiarimenti su ACE-inibitori in soluzione iniettabile per la crisi renale sclerodermica (SRC) Highlights News
L'indisponibilità di ACEi non costituisce un rischio per la tutela della salute dei pazienti.
Mon Apr 22 00:00:00 CEST 2024 Access to medicinal productsScientific and Economic Committee: new rules adopted Highlights News
At the meeting of the AIFA Board of Directors on 17 April 2024, the rules governing the organisation and functioning of the Scientific and Economic Committee (CSE) were adopted.
Mon Apr 22 00:00:00 CEST 2024 The Agency > Technical and advisory committeesFarmaci per il trattamento del diabete mellito tipo 2: aggiornata la tabella B della Nota 100 Highlights News
Le modifiche introdotte sono successive all'aggiornamento dell'RCP di empagliflozin per quanto riguarda l'uso nella compromissione renale.
Wed Apr 17 00:00:00 CEST 2024 Pricing and reimbursement > AIFA NotesHepatitis C: update of 15 April 2024 concerning enrolled patients Highlights News
AIFA has published the updated weekly data concerning treatments with new second-generation direct acting antiviral agents (DAAs) for chronic hepatitis C, as collected by AIFA Monitoring registries.
Tue Apr 16 00:00:00 CEST 2024 Pricing and reimbursement > Monitoring RegistersMeeting 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 productsDifferiti fino all'8 luglio 2024 gli effetti della determina AIFA istitutiva della Nota 101 Highlights News
Fino all'8 luglio 2024 restano applicabili le modalità prescrittive e di erogazione vigenti anteriormente alla istituzione della nota.
Tue Apr 09 00:00:00 CEST 2024 Pricing and reimbursement > AIFA Notes