Nulibry (fosdenopterin)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- fosdenopterin
- Company
- Integral Pharma Solutions EU Limited
- Status
- Authorised
- Therapeutic area
- Metal Metabolism, Inborn Errors
- CHMP opinion
- Thu 21 Jul 2022
- EU approval
- Thu 15 Sep 2022
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/005378
- ATC
- A16AX19
- Official record
- www.ema.europa.eu
Indication
Nulibry is indicated for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.
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.