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


Midon 5 mg tablets



Lexon Pharmaceuticals (Ireland) LimitedPPA23176/013/001

Main Information

Trade NameMidon 5 mg tablets
Active SubstancesMidodrine hydrochloride
Dosage FormTablet
Licence HolderLexon Pharmaceuticals (Ireland) Limited
Licence NumberPPA23176/013/001

Group Information

ATC CodeC01CA Adrenergic and dopaminergic agents
C01CA17 midodrine

Status

License statusAuthorised
Licence Issued25/08/2017
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceThis authorisation permits the holder to parallel-distribute product marketed in Ireland under the product authorisation number PA1547/006/002.
Marketing StatusUnknown

Documents

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

Generics Information

Interchangeable ListMidodrine 5mg Tablets
Interchangeable List CodeIC0120-001-002
Interchangeable List DocumentPDF of Interchangeable List
« Back