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France· FR:69548508

STIVARGA 40 mg, comprimé pelliculé

A medicinal product containing régorafénib monohydraté, registered in France by BAYER AG (ALLEMAGNE), on the national reimbursement list.

Reimbursed in France (Assurance maladie)

Checked against Base de données publique des médicaments — BDPM (France) on

Informational only — not a medical device.

SOURCE REGISTER · FRBase de données publique des médicament…normalisedSTIVARGA 40 mg, comprimé pelliculéATC—REGISTER NO.FR:69548508PACKS LISTED1CHECKEDSeptember 12, 2026

The record

At a glance

Base de données publique des médicaments — BDPM (France)
Active substance
RÉGORAFÉNIB MONOHYDRATÉ
Manufacturer
BAYER AG (ALLEMAGNE)
Country
France (FR)
ATC code
—
Reimbursed
Yes
Source register
Base de données publique des médicaments — BDPM (France)
Last checked
September 12, 2026

Packs & prices · 1

1 priced
  • cip13
    3400927520006
    3 flacon(s) polyéthylène haute densité (PEHD) de 28 comprimé(s)
    EUR 2.15

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Régorafénib monohydraté in 15 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All régorafénib monohydraté products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Stivarga
  • Liechtenstein · Stivarga
  • Norway · Stivarga

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 Base de données publique des médicaments — BDPM (France). 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/ab8a6aec-fbc8-4f4f-8fa2-3244e5e7b4d1
GET /v1/drugs/ab8a6aec-fbc8-4f4f-8fa2-3244e5e7b4d1?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.

{
  "cis": "69548508",
  "date_amm": "2013-08-26",
  "type_amm": "Procédure centralisée",
  "numero_ue": "EU/1/13/858",
  "substance": "RÉGORAFÉNIB MONOHYDRATÉ",
  "statut_amm": "Autorisation active",
  "statut_bdm": null,
  "forme_pharmaceutique": "comprimé pelliculé",
  "voies_administration": "orale",
  "etat_commercialisation": "Commercialisée",
  "surveillance_renforcee": "Non"
}

See everything about régorafénib monohydraté.

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.