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


Zepatier

50/100 mg/mg Film-coated tablet

Merck Sharp & Dohme LtdEU/1/16/1119/001

Main Information

Trade NameZepatier
Active SubstancesGrazoprevir
Elbasvir
Strength50/100 mg/mg
Dosage FormFilm-coated tablet
Licence HolderMerck Sharp & Dohme Ltd
Licence NumberEU/1/16/1119/001

Group Information

ATC CodeJ05AX Other antivirals
J05AX68 ZZZ Other AntiVirals

Status

Authorised/WithdrawnAuthorised
Licence Issued
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back