My HPRA: Register

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


Lenalidomide Krka d.d. Novo mesto 10 mg hard capsules



KRKA, d.d., Novo mestoEU/1/20/1520/007-008

Main Information

Trade NameLenalidomide Krka d.d. Novo mesto 10 mg hard capsules
Active SubstancesLenalidomide hydrochloride hydrate
Dosage FormCapsule, hard
Licence HolderKRKA, d.d., Novo mesto
Licence NumberEU/1/20/1520/007-008

Group Information

ATC CodeL04AX04 lenalidomide

Status

License statusWithdrawn
Withdrawn Date11/09/2023
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

Generics Information

Interchangeable ListLenalidomide 10mg Capsules
Interchangeable List CodeIC0125-002-001
Interchangeable List DocumentPDF of Interchangeable List
« Back
Follow medicine

Print