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

Dabigatran Etexilate Krka 150 mg hard capsules

KRKA, d.d., Novo mestoPA1347/110/003

Main Information

Trade NameDabigatran Etexilate Krka 150 mg hard capsules
Active SubstancesDabigatran etexilate mesilate
Dosage FormCapsule, hard
Licence HolderKRKA, d.d., Novo mesto
Licence NumberPA1347/110/003

Group Information

ATC CodeB01AE07 dabigatran etexilate


License statusAuthorised
Licence Issued12/01/2024
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusNot marketed


Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
« Back