Medicine
Iqirvo 80 mg tablet
Iqirvo 80 mg tablet is a prescription medicine containing Elafibranor for oral use, marketed by Ipsen Biopharmaceuticals, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at room temperature 15°C to 30°C (59°F to 86° F). Store in the original…
Key facts
- Active ingredient (INN)
- Elafibranor
- Brand
- Iqirvo
- Strength
- 80 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Ipsen Biopharmaceuticals
- Manufacturer
- Ipsen Biopharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at room temperature 15°C to 30°C (59°F to 86° F). Store in the original package (bottle and carton) to protect from moisture and light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A05AX06 Elafibranor
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 June 2024
- Identifiers
- RxCUI 2684946, 2684952DailyMed set ID d78aa14f-6ec1-4b1d-a4ae-e48658137a25NDC 15054-0080Application NDA218860
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle | 15054-0080-1 | Ipsen Biopharmaceuticals | 10 June 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Elafibranor is a peroxisome proliferator-activated receptor agonist indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Elafibranor for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about ElafibranorFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- IQIRVO prescribing information (Ipsen Biopharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Iqirvo: European public assessment report (EPAR) · European Medicines Agency
Need Iqirvo 80 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.