Regulatory PathRegulatory requirements compared

Active substance

Tegomil

Open in the medicines table

EMA European Union — centrally authorised medicines

Riulvy Neuraxpharm Pharmaceuticals S.L. · Authorised · authorised 28 Jul 2025 · ATC L04AX10

Therapeutic indication (EMA)

Riulvy is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
TEGOMIL FUMARATE NEURAXPHARM 174 MG GASTRO-RESISTANT HARD CAPSULESPL 49718/0151NEURAXPHARM UK LIMITEDPOM
TEGOMIL FUMARATE NEURAXPHARM 348 MG GASTRO-RESISTANT HARD CAPSULESPL 49718/0147NEURAXPHARM UK LIMITEDPOM

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.