France· FR:68487454
OGSIVEO 100 mg, comprimé pelliculé
A medicinal product containing dibromhydrate de nirogacéstat, registered in France by MERCK EUROPE (PAYS-BAS).
Checked against Base de données publique des médicaments — BDPM (France) on
Informational only — not a medical device.
The record
At a glance
Base de données publique des médicaments — BDPM (France)- Active substance
- DIBROMHYDRATE DE NIROGACÉSTAT
- Manufacturer
- MERCK EUROPE (PAYS-BAS)
- Country
- France (FR)
- ATC code
- —
- Reimbursed
- No
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 1
- cip133400930325278plaquette(s) thermoformée(s) PVC PVDC aluminium de 56 comprimé(s)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Dibromhydrate de nirogacéstat in 10 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesOGSIVEOSpringWorks Therapeutics, Inc.
- SwitzerlandOgsiveo 100 mg, FilmtablettenMerck (Schweiz) AG
- CzechiaOGSIVEOMerck Europe B.V., Amsterdam
- SpainOGSIVEO 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULAMerck Europe B.V.
- FinlandOgsiveoMerck Europe B.V.
- BelgiumOgsiveo 100 mgMerck Europe
- IcelandOgsiveoMerck Europe B.V.*
- PolandOgsiveoSpringWorks Therapeutics Ireland Limited
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Ogsiveo
- Liechtenstein · Ogsiveo
- Norway · Ogsiveo
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/28b0efa2-1c15-4e4b-b7fa-2294197bc03d GET /v1/drugs/28b0efa2-1c15-4e4b-b7fa-2294197bc03d?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": "68487454",
"date_amm": "2025-08-14",
"type_amm": "Procédure centralisée",
"numero_ue": "EU/1/25/1932",
"substance": "DIBROMHYDRATE DE NIROGACÉSTAT",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "comprimé pelliculé",
"voies_administration": "orale",
"etat_commercialisation": "Commercialisée",
"surveillance_renforcee": "Oui"
}See everything about dibromhydrate de nirogacéstat.
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.