France· FR:68844504
ORAVERSE 400 microgrammes/1,7 ml, solution injectable
A medicinal product containing mésilate de phentolamine, registered in France by SEPTODONT HOLDING.
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
- MÉSILATE DE PHENTOLAMINE
- Manufacturer
- SEPTODONT HOLDING
- 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
- cip13340092195835510 cartouche(s) en verre de 1,7 ml
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Mésilate de phentolamine in 5 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesOraverseSeptodont, Inc.
- United KingdomPhentolamine 10mg/1ml solution for injection ampoulesSpecial Order
- CanadaORAVERSESEPTODONT
- Japanフェントラミンメシル酸塩ノバルティス ファーマ
- NetherlandsRegitine, 10 mg/ml oplossing voor injectieACE Pharmaceuticals B.V.
Authorised across Europe · EMA
The same active substance is authorised in 4 EEA countries. Names it is sold under:
- Spain · Oraverse
- United Kingdom (Northern Ireland) · Phentolamine Mesilate Roma Pharmaceuticals
- Italy · Oraverse
- Netherlands · Regitine
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/1c6a3760-f94b-4a46-953a-5dbfcc0ff4d6 GET /v1/drugs/1c6a3760-f94b-4a46-953a-5dbfcc0ff4d6?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": "68844504",
"date_amm": "2012-01-27",
"type_amm": "Procédure décentralisée",
"numero_ue": null,
"substance": "MÉSILATE DE PHENTOLAMINE",
"statut_amm": "Autorisation abrogée",
"statut_bdm": "Warning disponibilité",
"forme_pharmaceutique": "solution injectable",
"voies_administration": "dentaire",
"etat_commercialisation": "Non commercialisée",
"surveillance_renforcee": "Non"
}See everything about mésilate de phentolamine.
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.