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


By-Madol SR 100 mg prolonged-release capsules, hard



EthypharmPA0549/016/002

Main Information

Trade NameBy-Madol SR 100 mg prolonged-release capsules, hard
Active SubstancesTramadol hydrochloride
Dosage FormProlonged-release capsule, hard
Licence HolderEthypharm
Licence NumberPA0549/016/002

Group Information

ATC CodeN02AX Other opioids
N02AX02 tramadol

Status

License statusAuthorised
Licence Issued27/10/2006
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusNot marketed

Documents

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

Generics Information

Interchangeable List CodeIC0074-024-030
Interchangeable List DocumentPDF of Interchangeable List
« Back