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


Trandate 5mg/ml Solution for Injection



RPH Pharmaceuticals ABPA1638/006/001

Main Information

Trade NameTrandate 5mg/ml Solution for Injection
Active SubstancesLabetalol hydrochloride
Dosage FormSolution for injection
Licence HolderRPH Pharmaceuticals AB
Licence NumberPA1638/006/001

Group Information

ATC CodeC07AG Alpha and beta blocking agents
C07AG01 labetalol

Status

License statusAuthorised
Licence Issued19/07/1993
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 StatusMarketed

Documents

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