Overview

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.

Amifampridine Serb can only be obtained with a prescription and treatment with this medicine should only be started under the supervision of a doctor experienced in treating LEMS.

The recommended starting dose of Amifampridine Serb is 15 mg per day, which can be increased by 5 mg every four to five days up to a maximum of 60 mg per day. Amifampridine Serb is taken in divided doses, three or four times a day, and a single dose should not be more than 20 mg. Amifampridine Serb should be taken with food.

For more information about using Amifampridine Serb, see the package leaflet or contact your doctor or pharmacist.

For muscles to contract, nerves have to transmit electrical impulses to the muscles through a chemical messenger called acetylcholine. Acetylcholine is released from the nerve endings during a period of ‘depolarisation’. The active substance in Amifampridine Serb, amifampridine, is a potassium channel blocker, which prevents charged potassium particles from leaving the nerve cells. This prolongs the period of depolarisation, allowing more time for the nerves to release acetylcholine and so stimulate the muscles to contract.

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Firdapse, and do not need to be repeated for Amifampridine Serb.

As for every medicine, the company provided data on the quality of Amifampridine Serb. There was no need for ‘bioequivalence’ studies to investigate whether Amifampridine Serb is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because the composition of Amifampridine Serb is the same as the reference medicine and the active substance in both products is expected to be absorbed in the same way.

Because Amifampridine Serb is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.

The European Medicines Agency concluded that, in accordance with EU requirements, Amifampridine Serb has been shown to be comparable to Firdapse. Therefore, the Agency’s view was that, as for Firdapse, the benefits of Amifampridine Serb outweigh the identified risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Amifampridine Serb have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Amifampridine Serb are continuously monitored. Suspected side effects reported with Amifampridine Serb are carefully evaluated and any necessary action taken to protect patients.

Amifampridine Serb received a marketing authorisation valid throughout the EU on 19 May 2022.

Amifampridine SERB : EPAR - Medicine Overview

български (BG) (182.19 KB - PDF)
español (ES) (158.54 KB - PDF)
čeština (CS) (179.43 KB - PDF)
dansk (DA) (156.67 KB - PDF)
Deutsch (DE) (160.21 KB - PDF)
eesti keel (ET) (145.37 KB - PDF)
ελληνικά (EL) (183.16 KB - PDF)
français (FR) (158.09 KB - PDF)
hrvatski (HR) (176.7 KB - PDF)
italiano (IT) (155.97 KB - PDF)
latviešu valoda (LV) (194.5 KB - PDF)
lietuvių kalba (LT) (178.77 KB - PDF)
magyar (HU) (178.75 KB - PDF)
Malti (MT) (181.2 KB - PDF)
Nederlands (NL) (158.37 KB - PDF)
polski (PL) (183.15 KB - PDF)
português (PT) (158.18 KB - PDF)
română (RO) (175.26 KB - PDF)
slovenčina (SK) (179.27 KB - PDF)
slovenščina (SL) (175.89 KB - PDF)
Suomi (FI) (155.99 KB - PDF)
svenska (SV) (155.74 KB - PDF)

Amifampridine Serb : EPAR - Risk management plan summary

Product information

Amifampridine Serb : EPAR - Product Information

български (BG) (323.07 KB - PDF)
español (ES) (251.02 KB - PDF)
čeština (CS) (297.13 KB - PDF)
dansk (DA) (237.14 KB - PDF)
Deutsch (DE) (253.52 KB - PDF)
eesti keel (ET) (208.38 KB - PDF)
ελληνικά (EL) (341.58 KB - PDF)
français (FR) (428.59 KB - PDF)
hrvatski (HR) (278.39 KB - PDF)
íslenska (IS) (219.98 KB - PDF)
Gaeilge (GA) (255.13 KB - PDF)
italiano (IT) (205.66 KB - PDF)
latviešu valoda (LV) (296.04 KB - PDF)
lietuvių kalba (LT) (279.47 KB - PDF)
magyar (HU) (283.36 KB - PDF)
Malti (MT) (412.64 KB - PDF)
Nederlands (NL) (305.75 KB - PDF)
norsk (NO) (220.01 KB - PDF)
polski (PL) (340.24 KB - PDF)
português (PT) (204.17 KB - PDF)
română (RO) (299.23 KB - PDF)
slovenčina (SK) (290.31 KB - PDF)
slovenščina (SL) (271.19 KB - PDF)
Suomi (FI) (262.15 KB - PDF)
svenska (SV) (248.23 KB - PDF)

Globe icon

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Amifampridine Serb : EPAR - All authorised presentations

български (BG) (65.99 KB - PDF)
español (ES) (48.94 KB - PDF)
čeština (CS) (55.58 KB - PDF)
dansk (DA) (49.09 KB - PDF)
Deutsch (DE) (49.67 KB - PDF)
eesti keel (ET) (104.63 KB - PDF)
ελληνικά (EL) (65.81 KB - PDF)
français (FR) (48.85 KB - PDF)
hrvatski (HR) (65.79 KB - PDF)
íslenska (IS) (49.34 KB - PDF)
Gaeilge (GA) (48.66 KB - PDF)
italiano (IT) (49.19 KB - PDF)
latviešu valoda (LV) (74.83 KB - PDF)
lietuvių kalba (LT) (68.28 KB - PDF)
magyar (HU) (58.25 KB - PDF)
Malti (MT) (66.39 KB - PDF)
Nederlands (NL) (49.25 KB - PDF)
norsk (NO) (48.05 KB - PDF)
polski (PL) (56 KB - PDF)
português (PT) (48.43 KB - PDF)
română (RO) (66.57 KB - PDF)
slovenčina (SK) (58.9 KB - PDF)
slovenščina (SL) (57.27 KB - PDF)
Suomi (FI) (47.39 KB - PDF)
svenska (SV) (48.89 KB - PDF)

Product details

Name of medicine
Amifampridine SERB
Active substance
amifampridine phosphate
International non-proprietary name (INN) or common name
amifampridine
Therapeutic area (MeSH)
  • Lambert-Eaton Myasthenic Syndrome
  • Paraneoplastic Syndromes, Nervous System
  • Nervous System Neoplasms
  • Paraneoplastic Syndromes
  • Nervous System Diseases
  • Autoimmune Diseases of the Nervous System
  • Neurodegenerative Diseases
  • Neuromuscular Diseases
  • Neuromuscular Junction Diseases
  • Immune System Diseases
  • Autoimmune Diseases
  • Autoimmune Diseases of the Nervous System
  • Cancer
  • Neoplasms
Anatomical therapeutic chemical (ATC) code
N07XX05

Pharmacotherapeutic group

Other nervous system drugs

Therapeutic indication

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

Authorisation details

EMA product number
EMEA/H/C/005839

Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Marketing authorisation holder
SERB SA

Avenue Louise 480
1050 Brussels
Belgium

Opinion adopted
24/03/2022
Marketing authorisation issued
19/05/2022

Assessment history

Amifampridine Serb : EPAR - Public Assessment Report

CHMP summary of positive opinion for Amifampridine SERB

This page was last updated on

How useful do you find this page?

Average: