The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Venclyxto



AbbVie LtdEU/1/16/1138/003-004

Main Information

Trade NameVenclyxto
Active SubstancesVenetoclax
Dosage FormFilm-coated tablet
Licence HolderAbbVie Ltd
Licence NumberEU/1/16/1138/003-004

Group Information

ATC CodeL01X OTHER ANTINEOPLASTIC AGENTS

Status

License statusAuthorised
Licence Issued05/12/2016
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website

Educational Materials - Patient

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