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


Epethinan 20 mg/10 mg prolonged release tablet



Acino AG PA2168/001/003

Main Information

Trade NameEpethinan 20 mg/10 mg prolonged release tablet
Active SubstancesOXYCODONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE
Dosage FormProlonged-release tablet
Licence HolderAcino AG
Licence NumberPA2168/001/003

Group Information

ATC CodeN02AA Natural opium alkaloids
N02AA55 oxycodone, combinations

Status

License statusWithdrawn
Withdrawn Date29/10/2021
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 1988 (S.I. No. 328 of 1988), as amended.
Marketing StatusNot marketed

Documents

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

Generics Information

Interchangeable List CodeIC0102-061-024
Interchangeable List DocumentPDF of Interchangeable List
« Back