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


Rebetol



Merck Sharp & Dohme BVEU/1/99/107/005

Main Information

Trade NameRebetol
Active SubstancesRibavirin
Dosage FormCapsule, hard
Licence HolderMerck Sharp & Dohme BV
Licence NumberEU/1/99/107/005

Group Information

ATC CodeJ05AB Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05AB04 ribavirin

Status

License statusWithdrawn
Withdrawn Date18/10/2023
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 CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back