Vamorolone

Agamree 40 MG/ML Suspension Oral

4000 mg suspensión oralSpainMarketedAuthorised 9 May 2024

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.

AgamreeEuropean UnionAuthorised

AgamreeCanada · 40 MG / ML · Suspension · Kye Pharmaceuticals INC.Same brand
AgamreeEuropean Union · Santhera Pharmaceuticals (Deutschland) GmbHSame brand
AgamreeCroatiaSame brand
AgamreeItaly · Sospensione orale · Santhera Pharmaceuticals (Deutschland) GMBHSame brand
AGAMREE 40 mg/ml suspensie voor oraal gebruikNetherlands · Suspensie voor oraal gebruik · Santhera Pharmaceuticals (Deutschland) GmbHSame brand
AgamreeUnited States · 40MG/ML · suspension · Catalyst Pharms

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Vamorolone

Agamree 40 MG/ML Suspension Oral

4000 mg suspensión oralSpainMarketedAuthorised 9 May 2024

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.

AgamreeEuropean 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

Packs

Pack	Code	Status
AGAMREE 40 MG/ML SUSPENSION ORAL, 1 frasco de 100 ml	764893

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.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 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: Vamorolone
Strength: 4000 mg
Dosage form: suspensión oral
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 9 May 2024
Registration: 1231776001
Marketing authorisation holder: Santhera Pharmaceuticals Gmbh
Procedure: EU centralised
Supply: Uso Hospitalario
EU number: EU/1/23/1776