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France· FR:65045274

COTELLIC 20 mg, comprimé pelliculé

A medicinal product containing hémifumarate de cobimétinib, registered in France by ROCHE REGISTRATION (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…normalisedCOTELLIC 20 mg, comprimé pelliculéATC—REGISTER NO.FR:65045274PACKS LISTED1CHECKEDSeptember 12, 2026

The record

At a glance

Base de données publique des médicaments — BDPM (France)
Active substance
HÉMIFUMARATE DE COBIMÉTINIB
Manufacturer
ROCHE REGISTRATION (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
    3400930037553
    3 plaquette(s) thermoformée(s) PVC PVDC de 21 comprimé(s)
    EUR 4.93

Regulatory notes

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

Same medicine, other countries

Hémifumarate de cobimétinib in 14 other countries

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

All hémifumarate de cobimétinib products

Authorised across Europe · EMA

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

  • Iceland · Cotellic
  • Liechtenstein · Cotellic
  • Norway · Cotellic

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/b31b9f30-68b4-4d4c-a824-532c4386168c
GET /v1/drugs/b31b9f30-68b4-4d4c-a824-532c4386168c?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": "65045274",
  "date_amm": "2015-11-20",
  "type_amm": "Procédure centralisée",
  "numero_ue": "EU/1/15/1048",
  "substance": "HÉMIFUMARATE DE COBIMÉTINIB",
  "statut_amm": "Autorisation active",
  "statut_bdm": null,
  "forme_pharmaceutique": "comprimé pelliculé",
  "voies_administration": "orale",
  "etat_commercialisation": "Commercialisée",
  "surveillance_renforcee": "Non"
}

See everything about hémifumarate de cobimétinib.

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.