United States· US:15054-0080_614b2fb1-3b17-49e1-a63d-869acaafa72e
IQIRVO
A elafibranor product containing elafibranor, registered in United States by Ipsen Biopharmaceuticals, Inc.. The same ATC class is registered in 12 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Elafibranor is registered in 12 of 19 countries.
Countries holding a registration under ATC A05AX06 (elafibranor), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 8 of them publish a price we can compare per daily dose
Elafibranor · ATC A05AX06
12 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- ELAFIBRANOR
- Manufacturer
- Ipsen Biopharmaceuticals, Inc.
- Country
- United States (US)
- ATC code
- A05AX06
- ATC class
- Elafibranor
- Defined daily dose
- 80 mg, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- August 16, 2026
Packs & prices · 2
- ndc1115054-0080-1
- ndc1115054008011 BOTTLE in 1 CARTON (15054-0080-1) / 30 TABLET, FILM COATED in 1 BOTTLE
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Elafibranor in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaIQIRVOIPSEN PHARMA S.A.S., Paříž
- SpainIQIRVO 80 MG COMPRIMIDOS RECUBIERTOS CON PELICULAIpsen Pharma
- FinlandIqirvoIpsen Pharma
- FranceIQIRVO 80 mg, comprimé pelliculéIPSEN PHARMA
- IrelandIqirvo 80 mg film-coated tabletsIpsen Pharma
- IcelandIqirvoIpsen Pharma
- NetherlandsIqirvo 80 mg filmomhulde tablettenIpsen Pharma
- NorwayIqirvoIpsen Pharma
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Iqirvo
- Liechtenstein · Iqirvo
- Norway · Iqirvo
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/ba423025-1073-4a1d-9b01-d6c8a660c1e5 GET /v1/drugs/ba423025-1073-4a1d-9b01-d6c8a660c1e5?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"source": "ndc",
"strength": "80",
"substance": "ELAFIBRANOR",
"productndc": "15054-0080",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA218860",
"marketing_category": "NDA"
}See everything about elafibranor.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.