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

Modafinil Bluefish 100 mg Tablets

Bluefish Pharmaceuticals ABPA1436/031/001

Main Information

Trade NameModafinil Bluefish 100 mg Tablets
Active SubstancesModafinil
Dosage FormTablet
Licence HolderBluefish Pharmaceuticals AB
Licence NumberPA1436/031/001

Group Information

ATC CodeN06BA Centrally acting sympathomimetics
N06BA07 modafinil


License statusAuthorised
Licence Issued12/06/2015
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (See: Summary of Product Characteristics, section 4.2).
Marketing StatusMarketed


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