Regulatory PathRegulatory requirements compared

Active substance

Fampridine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
FAMPYRA 10MG Prolonged-release tablet10 mgProlonged-release tablet · Oral use56 Tablet ContainerSAR 1133.90NCE · PrescriptionAcorda Therapeutics lreland LimitedValid
Indications — CHI Daman Drug Formulary

MULTIPLE SCLEROSIS

EMA European Union — centrally authorised medicines

Fampyra Merz Therapeutics GmbH · Authorised · authorised 20 Jul 2011 · ATC N07XX07

Therapeutic indication (EMA)

Fampyra is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (Expanded Disability Status Scale 4-7).

Fampridine Accord Accord Healthcare S.L.U. · Authorised · authorised 24 Sep 2020 · ATC N07XX07

Therapeutic indication (EMA)

Fampridine Accord is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7).

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
FAMPYRA0237991010 MGTABLET (EXTENDED-RELEASE) · ORALMERZ THERAPEUTICS GMBH
PMS-FAMPRIDINE0249621610 MGTABLET (EXTENDED-RELEASE) · ORALPHARMASCIENCE INC
TARO-FAMPRIDINE0248239810 MGTABLET (EXTENDED-RELEASE) · ORALTARO PHARMACEUTICALS INC

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.