Page contentsPage contents Key facts Decision Key facts Active substance ribitol Therapeutic area Congenital, familial and genetic disorders Decision number EMA/PE/0000224955 PIP number EMA/PE/0000224955 Pharmaceutical form(s) Powder for oral useAge appropriate oral dosage formulation Condition(s) / indication(s) Treatment of limb-girdle muscular dystrophy Route(s) of administration Oral use Contact for public enquiries BridgeBio Europe B.V. E-mail: info@mlbiosolutions.comTel: (704) 285-8153 Decision type PM: decision on the application for modification of an agreed PIP Decision date 03/01/2025 Compliance check done No Decision EMA/PE/0000224955 : EMA decision of 3 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for ribitolAdopted Reference Number: EMADOC-1700519818-1802285 English (EN) (248.45 KB - PDF)First published: 12/03/2026 View Share this page