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EMA Product

Amifampridine SERB

Product approved by European Medicines Agency (EU)

Basic Information

Amifampridine SERB

Regulatory Information

EMEA/H/C/005839

Authorised

May 19, 2022

March 24, 2022

May 24, 2022

Company Information

Belgium

Avenue Louise 480 1050 Brussels

SERB SA

Drug Classification

Generic Medicine

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.

Overview Summary

Amifampridine Serb is a medicine used to treat the symptoms of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a disease in which patients have muscle weakness because of a failure of the nerves to transmit electrical impulses to the muscles. Amifampridine Serb contains the active substance amifampridine and is a ‘generic medicine’. This means that Amifampridine Serb contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Firdapse. For more information on generic medicines, see the question-and-answer document [here](https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-generic-medicines_en.pdf).

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