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Irish Medicines Database · HPRA register

Rezdiffra 100 mg film-coated tablets

Authorisation EU/1/25/1962/003 · Madrigal Pharmaceuticals EU Limited

← All medicines

Rezdiffra 100 mg film-coated tablets

Licence EU/1/25/1962/003 · Unknown

Licence holder: Madrigal Pharmaceuticals EU Limited (all products →)
Active substance: Resmetirom
Dosage form: Film-coated tablet
Route of administration: Oral use
ATC code: A05
Prescription status: *** AWAITING VALUE ***
Legal basis: Full application (Article 8(3) of Directive No 2001/83/EC)

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 04 Jul 2026. This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.