EMA Authorised: Sapropterin Dipharma (sapropterin dihydrochloride) — Dipharma Arzneimittel GmbH

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Summary

The EMA authorised Sapropterin Dipharma (sapropterin dihydrochloride) for phenylketonuria, with Dipharma Arzneimittel GmbH as the marketing authorization holder…

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Diseases / indications

• Phenylketonuria

Drugs mentioned

• Sapropterin Dipharma (sapropterin dihydrochloride)

Snippet

Status: Authorised. Therapeutic area: Phenylketonurias. MAH: Dipharma Arzneimittel GmbH. Decision date: 18/12/2025