Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use


Product name: Flupirtine
Also marketed in the EU under the name(s): Awegal, Dolokadin, EFIRET, Flupigamma, Flupigil, Flupimal, Flupin, Flupirtina Midas, Flupirtina Winthrop, Flupirtinmaleat AbZ, Flupirtinmaleat AL, Flupirtinmaleat Midas, Flupirtinmaleat Viatris, Flupirtinmaleat Vitapharma, Flupirtinmaleat Winthrop, Flupirtinmaleat-CT, Flupirtinmaleat-Hormosan, Flupirtinmaleat-ratiopharm, Flupivil, Flupizen, Fluporol, Flupsadim, Katadolon, Metanor, Miflumal, Miphaflumix, Trancolong, Trancopal Dolo
Active substance: flupirtine
Indication: Flupirtine is indicated in the treatment of acute pain in adults and must only be used if treatment with other analgesics (e.g. non-steroidal anti-inflammatory drugs, weak opioids) is contraindicated.
Marketing Authorisation Holder: Teva GmbH

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
06/09/2013 Referral EMEA/H/A-107i/1363 (2013)5788 of 05/09/2013
03/03/2014 Corrigendum (2014)1482 of 28/02/2014