Berotralstat

Orladeyo 150 mg, harde capsule

Capsule, hardNetherlandsAuthorisedAuthorised 30 Apr 2021

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

OrladeyoEuropean UnionAuthorised

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

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Berotralstat

Orladeyo 150 mg, harde capsule

Capsule, hardNetherlandsAuthorisedAuthorised 30 Apr 2021

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

OrladeyoEuropean UnionAuthorised

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Orladeyo

United States · 110MG BASE, 150MG BASE · capsule · Biocryst

OrladeyoUnited States · 108MG BASE/PACKET, 132MG BASE/PACKET, 72MG BASE/PACKET … · pellets · Biocryst

Documents

The official texts, at the regulator.

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

College ter Beoordeling van Geneesmiddelen

College ter Beoordeling van Geneesmiddelen, Geneesmiddeleninformatiebank metadata, source update 07-10-2026; downloaded 08-10-2026; factual adaptation.

Licence: Conditional noncreative administrative factual metadata; no dataset-wide CC0 claim · Added 8 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Berotralstat
Dosage form: Capsule, hard
Route: Oraal gebruik
Register: Netherlands (CBG-MEB)
Status: Authorised
Status in the register: Ingeschreven
Authorised: 30 Apr 2021
Registration: EU/1/21/1544
Marketing authorisation holder: BioCryst Ireland Ltd
ATC code: B06AC06
Group: Blood and blood-forming organs
Procedure: EU centralised
Supply: Uitsluitend recept
EMA product number: EMEA/H/C/005138
EU number: EU/1/21/1544

Orladeyo 72 mg filmomhuld granulaat in sachetBerotralstat · Filmomhuld granulaatNetherlands

Orladeyo 96 mg filmomhuld granulaat in sachetBerotralstat · Filmomhuld granulaatNetherlands