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


Tramadol /Paracetamol Rowa 37.5 mg/325 mg Film-coated Tablets

37.5/325 milligram(s) Film-coated tablet

Rowa Pharmaceuticals LimitedPA0074/070/001

Main Information

Trade NameTramadol /Paracetamol Rowa 37.5 mg/325 mg Film-coated Tablets
Active SubstancesTramadol hydrochloride ep
Paracetamol
Strength37.5/325 milligram(s)
Dosage FormFilm-coated tablet
Licence HolderRowa Pharmaceuticals Limited
Licence NumberPA0074/070/001

Group Information

ATC CodeN02AJ Opioids in combination with non-opioid analgesics
N02AJ13 opiods in combination with non-opiod analgesics

Status

Authorised/WithdrawnAuthorised
Licence Issued07/07/2017
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

Generics Information

Interchangeable List CodeIC0077-133-014
Interchangeable List DocumentPDF of Interchangeable List
« Back