France· FR:62149015
OZALIN 2 mg/mL, solution buvable en récipient unidose
A medicinal product containing midazolam, registered in France by ISTITUTO GENTILI (ITALIE).
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
- MIDAZOLAM
- Manufacturer
- ISTITUTO GENTILI (ITALIE)
- 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
- cip13340095506001710 ampoules en verre jaune(brun) de 5 ml avec 10 canules filtrantes et 10 applicateurs gradués pour administration orale.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Midazolam in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- NorwayMidazolam SASykehusapotekene HF
- SpainOZALIN 2 MG/ML SOLUCION ORAL EN ENVASE UNIDOSISIstituto Gentili S.R.L.
- FinlandOzalinIstituto Gentili S.r.l.
- BelgiumOzalin 2 mg/mlIstituto Gentili
- NetherlandsOzalin 2 mg/ml drank in verpakking voor eenmalig gebruikIstituto Gentili S.r.l.
- PolandOzasedIstituto Gentili srl
- IrelandOzalin 2 mg/ml oral solution in single-dose containerIstituto Gentili S.r.l.
- United KingdomBuccolam 10mg/2ml oromucosal solution pre-filled oral syringesEthigen Ltd
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Dormicum, Epistatus
- Belgium · Midazolam Accord Healthcare, Midazolam Aguettant
- Bulgaria · Midazolam Kalceks, Мидазолам Хамелн
- Cyprus · Midazolam Accord, Midazolam B. Braun
- Czechia · Dormicum, Midazolam Accord
- Germany · Dormicum, Dormicum V
- Denmark · Epistatus, Midazolam "hameln"
- Estonia · Midazolam Kalceks
- Spain · Dormicum, Midazolam Accord
- Finland · Dormicum, Epistatus
- United Kingdom (Northern Ireland) · Hypnovel, Midazolam Accord Healthcare
- Greece · Dormicum, Dormipnol
- Croatia · Dormicum, Midazolam B. Braun
- Hungary · Dormicum, Epistatus
- Ireland · Epistatus, Hypnovel
- Iceland · Buccolam, Midazolam Accord
- Italy · Epistatus, Midazolam Accord Healthcare
- Liechtenstein · Buccolam
- Lithuania · Fulsed, Midazolam B. Braun
- Luxembourg · Midazolam Aguettant, Midazolam B. Braun
- Latvia · Fulsed, Midazolam B. Braun
- Malta · Midazolam Bp Accord Healthcare, Miprosed
- Netherlands · Dormicum, Midazolam Accord
- Norway · Buccolam, Epistatus
- Poland · Dormicum, Epistatus
- Portugal · Dormicum, Midazolam Accord
- Romania · Midazolam Desitin, Midazolam Hameln
- Sweden · Epistatus, Midazolam Accord
- Slovenia · Dormicum, Epistatus
- Slovakia · Midazolam Accord, Midazolam Hameln
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/905aaf15-ff89-4fa1-87f5-a836d61dc971 GET /v1/drugs/905aaf15-ff89-4fa1-87f5-a836d61dc971?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": "62149015",
"date_amm": "2018-10-17",
"type_amm": "Procédure décentralisée",
"numero_ue": null,
"substance": "MIDAZOLAM",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "solution buvable",
"voies_administration": "orale",
"etat_commercialisation": "Commercialisée",
"surveillance_renforcee": "Non"
}See everything about midazolam.
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.