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


FAMPYRA

10 Milligram Tablet Prolonged Release

Biogen Netherlands B.V.EU/1/11/699/001-002

Main Information

Trade NameFAMPYRA
Active SubstancesFAMPRIDINE (4-AMINOPYRIDINE)
Strength10 Milligram
Dosage FormTablet Prolonged Release
Licence HolderBiogen Netherlands B.V.
Licence NumberEU/1/11/699/001-002

Group Information

ATC CodeN07XX07 fampridine

Status

Authorised/WithdrawnAuthorised
Licence Issued20/07/2011
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceSubject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back