Kuvan (sapropterin)
- Region
- 🇪🇺 EU
- Active substance
- sapropterin
- Company
- BioMarin International Limited
- Status
- Authorised
- Therapeutic area
- Phenylketonurias
- EU approval
- Tue 02 Dec 2008
- Application
- EMEA/H/C/000943
- ATC
- A16AX07
- Official record
- www.ema.europa.eu
Indication
Kuvan is indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such treatment. Kuvan is also indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to such treatment.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Sapropterin Dipharma Authorised · Dipharma Arzneimittel GmbH
Follow Kuvan
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.