Resmetirom

Rezdiffra 100 MG Comprimidos Recubiertos con Pelicula

100 mg comprimido recubierto con películaSpainAuthorisedAuthorised 20 Oct 2025

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.

RezdiffraEuropean UnionAuthorised

RezdiffraEuropean Union · Madrigal Pharmaceuticals EU LimitedSame brand
RezdiffraCroatiaSame brand
RezdiffraItaly · Compressa rivestita con film · Madrigal Pharmaceuticals Eu LimitedSame brand
Rezdiffra 100 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Madrigal Pharmaceuticals EU LimitedSame brand
Rezdiffra 60 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Madrigal Pharmaceuticals EU LimitedSame brand

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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Resmetirom

Rezdiffra 100 MG Comprimidos Recubiertos con Pelicula

100 mg comprimido recubierto con películaSpainAuthorisedAuthorised 20 Oct 2025

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.

RezdiffraEuropean 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

Rezdiffra 80 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Madrigal Pharmaceuticals EU Limited

RezdiffraUnited States · 100MG, 60MG, 80MG · tablet · Madrigal

Packs

Pack	Code	Status
REZDIFFRA 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA, 28 comprimidos	768843

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: Resmetirom
Strength: 100 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Authorised
Status in the register: Autorizado, no comercializado
Authorised: 20 Oct 2025
Registration: 1251962003
Marketing authorisation holder: Madrigal Pharmaceuticals Eu Limited
Procedure: EU centralised
Supply: Diagnóstico Hospitalario
EU number: EU/1/25/1962

Spain