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


Arthrotec 50 modified-release tablets

50 mg/0.2 milligram(s) Modified-release tablet

Pfizer Healthcare IrelandPA0822/112/001

Main Information

Trade NameArthrotec 50 modified-release tablets
Active SubstancesDiclofenac sodium
Misoprostol
Strength50 mg/0.2 milligram(s)
Dosage FormModified-release tablet
Licence HolderPfizer Healthcare Ireland
Licence NumberPA0822/112/001

Group Information

ATC CodeM01AB Acetic acid derivatives and related substances
M01AB55 diclofenac, combinations

Status

Authorised/WithdrawnAuthorised
Licence Issued16/06/1993
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

Generics Information

Interchangeable List CodeIC0058-109-021
Interchangeable List DocumentPDF of Interchangeable List
« Back