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


Kyleena 19.5 mg intrauterine delivery system



PCO Manufacturing Ltd.PPA0465/476/001

Main Information

Trade NameKyleena 19.5 mg intrauterine delivery system
Active SubstancesLevonorgestrel
Dosage FormIntrauterine delivery system
Licence HolderPCO Manufacturing Ltd.
Licence NumberPPA0465/476/001

Group Information

ATC CodeG02BA Intrauterine contraceptives
G02BA03 plastic IUD with progestogen

Status

License statusAuthorised
Licence Issued25/06/2021
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown

Documents

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