Sweden· SE-20250227000039
Epistatus 10 mg/ml Munhålelösning
A medicinal product containing midazolam, registered in Sweden by SERB S.A..
Checked against Swedish Medical Products Agency (Sweden) on
Informational only — not a medical device.
The record
At a glance
Swedish Medical Products Agency (Sweden)- Active substance
- Midazolam
- Manufacturer
- SERB S.A.
- Country
- Sweden (SE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- Swedish Medical Products Agency (Sweden)
- Last checked
- October 1, 2026
Packs & prices · 1
- se_varunummer20250227000039
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.
- United KingdomBuccolam 10mg/2ml oromucosal solution pre-filled oral syringesMawdsley-Brooks & Company Ltd
- United StatesmidazolamSagent Pharmaceuticals
- CzechiaBUCCOLAMNeuraxpharm Pharmaceuticals, S.L., Barcelona
- NetherlandsBuccolam 10mg/2ml, oplossing voor oromucosaal gebruikLaboratorios Lesvi S.L.
- FinlandBUCCOLAMNeuraxpharm Pharmaceuticals S.L.
- BelgiumBuccolam 10 mgNeuraxpharm Pharmaceuticals
- GermanyDormicumCheplapharm Arzneimittel Gmbh
- PolandBuccolamNeuraxpharm Pharmaceuticals, S.L.
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
- France · Hypnovel, Midazolam Accord
- 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
- 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 Swedish Medical Products Agency (Sweden). 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/d436d751-33c1-4ccf-8693-053ff1e4ba69 GET /v1/drugs/d436d751-33c1-4ccf-8693-053ff1e4ba69?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.
{
"source": "lakemedelsverket",
"doc_types": [
"PL",
"SmPC",
"sRMP",
"sPAR",
"PAR"
],
"se_npl_id": "20250227000039",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20250227000039",
"product_doc_link": "https://docetp.mpa.se/LMF/Epistatus%2010%20mg%20per%20ml%20oromucosal%20solution%20SmPC_09001bee85252817.pdf"
}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.