Purpose of This Reference Page
This page identifies authoritative sources for educational information about resmetirom, MASH, liver fibrosis, prescribing information and medicine safety.
Resiliva is identified on this website as a product containing resmetirom in stated strengths of 80 mg and 100 mg. The references below primarily concern the established reference product REZDIFFRA and the active ingredient resmetirom. They do not independently establish Resiliva’s manufacturer, formulation, authenticity or regulatory authorization.
Readers should consult the latest available versions of official documents, as prescribing information and regulatory decisions can change.
1. U.S. Food and Drug Administration — REZDIFFRA Prescribing Information
The U.S. FDA-approved labeling provides information about REZDIFFRA’s indication, dosage, administration, warnings, precautions, adverse reactions and interactions.
It is an important source for understanding the reference product’s U.S. prescribing requirements.
Official source: DailyMed — REZDIFFRA prescribing information. <Cite refs={[“turn249135search3”]}/>
2. U.S. Food and Drug Administration — REZDIFFRA Drug Trials Snapshot
The FDA’s Drug Trials Snapshot summarizes the regulatory approval and clinical trial information for REZDIFFRA. It explains the medicine’s intended treatment population and provides an overview of the evidence reviewed for approval.
Official source: FDA — Drug Trials Snapshot: REZDIFFRA. <Cite refs={[“turn249135search8”]}/>
3. European Medicines Agency — REZDIFFRA European Public Assessment Report
The European Medicines Agency provides information about REZDIFFRA’s European authorization, therapeutic indication, clinical evidence, risks and product documentation.
The EMA reports that REZDIFFRA received conditional marketing authorization in the European Union on August 18, 2025. Its European indication concerns adults with noncirrhotic MASH and moderate to advanced liver fibrosis, in conjunction with diet and exercise.
Official source: European Medicines Agency — REZDIFFRA. <Cite refs={[“turn249135search0”]}/>
4. European Medicines Agency — REZDIFFRA Product Information
The European product-information documents provide the official summary of product characteristics, package leaflet, product composition, dosage instructions, warnings and other regulatory details for the European reference product.
These documents are particularly useful for checking the European labeling and identifying the responsible marketing authorization holder.
Official source: EMA — REZDIFFRA product information PDF. <Cite refs={[“turn249135search22”]}/>
5. Clinical Trial Evidence
The clinical evidence supporting resmetirom includes a pivotal study evaluating changes in MASH and liver fibrosis in patients with moderate to advanced fibrosis.
Clinical endpoints include resolution of MASH without worsening of fibrosis and improvement in fibrosis without worsening of MASH. These endpoints describe changes assessed under the study’s predefined criteria; they should not be interpreted as guarantees of individual benefit.
The FDA’s Drug Trials Snapshot and the European Medicines Agency’s assessment documents provide regulatory summaries of the evidence. The complete scientific publications should be consulted when detailed study methodology, statistical analysis or trial limitations are required.
6. Official Manufacturer Information for the Reference Product
Madrigal Pharmaceuticals is associated with the development and commercialization of REZDIFFRA. Official company information can provide additional context about the reference product and its regulatory materials.
Official source: REZDIFFRA information for healthcare professionals. <Cite refs={[“turn249135search10”]}/>
This source concerns REZDIFFRA and must not be presented as proof that Madrigal manufactures or authorizes Resiliva.
7. National Medicines Regulatory Authorities
For product-specific verification, consult the official medicines regulatory authority in the country where the product is supplied.
The relevant database or authority should be used to check the exact product name, active ingredient, strength, dosage form, manufacturer and authorization status. The appropriate authority depends on the jurisdiction.
A reference-product approval does not establish authorization for another brand containing the same active ingredient.
How These References Should Be Used
Official prescribing information should take priority when checking approved uses, dosage, administration, contraindications, interactions and safety warnings.
Regulatory assessment reports are useful for understanding the basis and limitations of an authorization. Clinical publications provide more detailed evidence about study design, results and uncertainty.
Every important medical statement on Resiliva.com should be connected to a source that actually supports it. Product-specific claims require product-specific evidence; information about REZDIFFRA should not be silently transferred to Resiliva.
Source Review and Updating
Reference documents should be reviewed periodically and whenever important regulatory or safety information changes.
If a source is superseded, the website should update the
affected content and reference details. The website should not claim that sources have been reviewed on a particular date unless that review has occurred.
Medical Disclaimer
This reference list is provided for educational purposes. It does not constitute an endorsement of Resiliva or confirm the product’s authenticity, manufacturing origin, formulation or regulatory status.
For personal treatment decisions, consult a qualified healthcare professional and the official prescribing information applicable to the exact medicine and jurisdiction.