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


BARACLUDE

0.05 Mg/Ml Oral Solution

Bristol Myers Squibb Pharma EEIGEU/1/06/343/05

Main Information

Trade NameBARACLUDE
Active SubstancesENTECAVIR
Strength0.05 Mg/Ml
Dosage FormOral Solution
Licence HolderBristol Myers Squibb Pharma EEIG
Licence NumberEU/1/06/343/05

Group Information

ATC CodeJ05AF10 entecavir

Status

Authorised/WithdrawnAuthorised
Licence Issued26/06/2006
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 Status

Documents

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