Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Madrigal Pharmaceuticals EU Limited, 1 Castlewood Avenue, Dublin, D06 H685, Ireland
Rezdiffra 60 mg film-coated tablets.
Rezdiffra 80 mg film-coated tablets.
Rezdiffra 100 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablet. Rezdiffra 60 mg film-coated tablets: White, oval film-coated tablets with "P60" debossed on one side and plain on the other side. Approximate tablet dimensions 6.4 mm x 12.2 mm. Rezdiffra 80 mg film-coated tablets: Yellow, oval film-coated tablets with "P80" debossed on one side and plain on the other side. Approximate tablet dimensions 7.1 mm x 13.5 mm. Rezdiffra 100 mg film-coated tablets: Beige to pinkish, oval film-coated tablets with "P100" debossed on one side and plain on the other side. Approximate tablet dimensions 7.6 mm x 14.6 mm. |
Rezdiffra 60 mg film-coated tablets: Each film-coated tablet contains 60 mg of resmetirom.
Rezdiffra 80 mg film-coated tablets: Each film-coated tablet contains 80 mg of resmetirom.
Rezdiffra 100 mg film-coated tablets: Each film-coated tablet contains 100 mg of resmetirom.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Resmetirom is a liver-directed partial agonist for the thyroid hormone receptor beta (THR-β). Stimulation of THR-β in the liver improves mitochondrial function and lipid metabolism, and increases fatty acid β-oxidation, thereby reducing lipotoxic liver fat, inflammation and liver fibrosis. Resmetirom's liver directed THR-β agonism is particularly relevant in the treatment of MASH and leads to minimal off-target activity on THR-α in tissues such as heart and bone. |
| List of Excipients |
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Tablet core: Microcrystalline cellulose Tablet coating: Rezdiffra 60 mg film-coated tablets Poly(vinyl alcohol) Rezdiffra 80 mg film-coated tablets Poly(vinyl alcohol) Rezdiffra 100 mg film-coated tablets Poly(vinyl alcohol) |
Rezdiffra film-coated tablets are supplied in PVC/PCTFE blisters with aluminium foil lidding.
Pack size of 28 film-coated tablets.
Madrigal Pharmaceuticals EU Limited, 1 Castlewood Avenue, Dublin, D06 H685, Ireland
EU/1/25/1962/001
EU/1/25/1962/002
EU/1/25/1962/003
| Drug | Countries | |
|---|---|---|
| REZDIFFRA | Austria, Estonia, France, Italy, Lithuania, United States |
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