Maapliv (amino acids)
OrphanExceptional circumstances
- Region
- 🇪🇺 EU
- Active substance
- amino acids
- Company
- Recordati Rare Diseases
- Status
- Authorised
- Therapeutic area
- Maple Syrup Urine Disease
- CHMP opinion
- Thu 22 May 2025
- EU approval
- Mon 28 Jul 2025
- Designations
- Orphan, Exceptional circumstances
- Application
- EMEA/H/C/005557
- ATC
- B05BA01
- Official record
- www.ema.europa.eu
Indication
Maapliv is indicated for the treatment of maple syrup urine disease (MSUD) presenting with an acute decompensation episode in patients from birth who are not eligible for an oral and enteral branched-chain amino acids free (BCAA- free) formulation.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.