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


Ambrobene 3 mg/ml Oral Solution



Teva Pharma B.V.PA0749/158/001

Main Information

Trade NameAmbrobene 3 mg/ml Oral Solution
Active SubstancesAMBROXOL HYDROCHLORIDE
Dosage FormOral solution
Licence HolderTeva Pharma B.V.
Licence NumberPA0749/158/001

Group Information

ATC CodeR05CB Mucolytics
R05CB06 ambroxol

Status

License statusWithdrawn
Withdrawn Date08/04/2019
Legal statusProduct not subject to medical prescription
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusNot marketed

Documents

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