EMA Authorised: Kuvan (sapropterin dihydrochloride) — BioMarin International Limited

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Summary

The European Medicines Agency has authorised Kuvan (sapropterin dihydrochloride) for phenylketonurias. The marketing authorization holder is BioMarin Internatio…

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Diseases / indications

• Phenylketonurias

Drugs mentioned

• KUVAN (Sapropterin dihydrochloride)

Snippet

Status: Authorised. Therapeutic area: Phenylketonurias. MAH: BioMarin International Limited. Decision date: 07/01/2026