AIFA Agenzia Italiana del Farmaco
Web activation and publication of monitoring forms
Registro Venetoclax according to Law 648/96
Users of the Drug Registers subject to Monitoring are informed that, following the publication of the AIFA Determine in the OJ n. 243 of and n. 247 of , starting from it is possible to use, in the NHS reimbursement regime, pursuant to Law no. of 23 December 1996.648, the medicinal product VENETOCLAX for the following therapeutic indication:
Treatment of relapsed/refractory acute myeloid leukaemia (AML), in combination with azacitidine or decitabine (in 648/96 regimen).
Please note that the prescriptions relating only to the indications reimbursed by the National Health Service, through the aforementioned publication, must be carried out in accordance with the criteria of eligibility and prescriptive appropriateness reported in the clinical card, downloadable from the list of «Active Registers and PT», accessible from the «Related Links» box.
Finally, it is specified that, starting from , the register in question is available on the web platform; therefore the regional referents are invited to proceed with the authorization of authorized health centers, accessing the system.
Monitoring Registers Office
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Source — https://www.univadis.it/viewarticle/attivazione-web-e-pubblicazione-schede-di-monitoraggio-registro-venetoclax-secondo-legge-64896