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EMA approval · 2025-09-30

EMA Authorised: Maapliv (glycine,L-alanine,L-arginine,L-aspartic acid,L-cysteine hydrochloride monohydrate,L-histidine,L-methionine,L-phenylalanine,L-proline,L-serine,L-threonine,L-tryptophan,L-tyrosine,L-glutamic acid,L-lysine monohydrate,taurine) — Recordati Rare Diseases

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Summary

EMA authorised Maapliv for Maple Syrup Urine Disease, an amino-acid based product developed for an orphan indication by Recordati Rare Diseases.

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Diseases / indications

Drugs mentioned

  • Maapliv

Snippet

Status: Authorised. Therapeutic area: Maple Syrup Urine Disease. MAH: Recordati Rare Diseases. Decision date: 28/07/2025. Orphan medicine