EMA Revoked: Dimethyl fumarate Mylan (dimethyl fumarate) — Mylan Ireland Limited

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Summary

EMA revoked the marketing authorization for dimethyl fumarate (Mylan Ireland Limited) intended for multiple sclerosis (relapsing-remitting).

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Diseases / indications

• Multiple Sclerosis Relapsing-remitting

Drugs mentioned

• Dimethyl fumarate (Dimethyl fumarate)

Snippet

Status: Revoked. Therapeutic area: Multiple Sclerosis, Relapsing-Remitting. MAH: Mylan Ireland Limited. Decision date: 13/12/2023