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


Betahistine dihydrochloride 16mg tablets



Accord Healthcare Ireland Ltd.PA2315/078/002

Main Information

Trade NameBetahistine dihydrochloride 16mg tablets
Active SubstancesBetahistine dihydrochloride
Dosage FormTablet
Licence HolderAccord Healthcare Ireland Ltd.
Licence NumberPA2315/078/002

Group Information

ATC CodeN07CA Antivertigo preparations
N07CA01 betahistine

Status

License statusAuthorised
Licence Issued07/10/2011
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusMarketed

Documents

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

Generics Information

Interchangeable ListBetahistine 16mg Tablets
Interchangeable List CodeIC0084-038-002
Interchangeable List DocumentPDF of Interchangeable List
« Back