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


Sitagliptin/Metformin hydrochloride Krka 50 mg/1000 mg film-coated tablets



KRKA, d.d., Novo mestoPA1347/100/002

Main Information

Trade NameSitagliptin/Metformin hydrochloride Krka 50 mg/1000 mg film-coated tablets
Active SubstancesSitagliptin
Metformin Hydrochloride
Dosage FormFilm-coated tablet
Licence HolderKRKA, d.d., Novo mesto
Licence NumberPA1347/100/002

Group Information

ATC CodeA10BD07 metformin and sitagliptin

Status

License statusAuthorised
Licence Issued19/02/2021
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 StatusMarketed

Documents

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

Generics Information

Interchangeable List CodeIC0070-122-003
Interchangeable List DocumentPDF of Interchangeable List
« Back