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


Topamax 100 mg Film-Coated Tablets



PCO Manufacturing Ltd.PPA0465/196/003

Main Information

Trade NameTopamax 100 mg Film-Coated Tablets
Active SubstancesTopiramate
Dosage FormFilm-coated tablet
Licence HolderPCO Manufacturing Ltd.
Licence NumberPPA0465/196/003

Group Information

ATC CodeN03AX Other antiepileptics
N03AX11 topiramate

Status

License statusAuthorised
Licence Issued16/03/2007
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 PA0748/012/003.
Marketing StatusUnknown

Documents

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