Sapropterin Dipharma (sapropterin)
- Region
- 🇪🇺 EU
- Active substance
- sapropterin
- Company
- Dipharma Arzneimittel GmbH
- Status
- Authorised
- Therapeutic area
- Phenylketonurias
- CHMP opinion
- Thu 16 Dec 2021
- EU approval
- Wed 16 Feb 2022
- Designations
- Generic
- Application
- EMEA/H/C/005646
- ATC
- A16AX07
- Official record
- www.ema.europa.eu
Indication
Sapropterin Dipharma 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. Sapropterin Dipharma 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
- 🇪🇺 Kuvan Authorised · BioMarin International Limited
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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.