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


Apeneta 200 mg prolonged-release tablets



KRKA, d.d., Novo mestoPA1347/105/004

Main Information

Trade NameApeneta 200 mg prolonged-release tablets
Active SubstancesTapentadol maleate hemihydrate
Dosage FormProlonged-release tablet
Licence HolderKRKA, d.d., Novo mesto
Licence NumberPA1347/105/004

Group Information

ATC CodeN02AX06 tapentadol

Status

License statusAuthorised
Licence Issued22/10/2021
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceThis product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 2017
Marketing StatusMarketed

Documents

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