Ireland· IE-PA-EU/1/11/709/002
BUCCOLAM 5 mg oromucosal solution
A midazolam product containing midazolam, registered in Ireland by Laboratorios Lesvi, S.L.. The same ATC class is registered in 14 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Midazolam is registered in 14 of 19 countries.
Countries holding a registration under ATC N05CD08 (midazolam), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 9 of them publish a price we can compare per daily dose
Midazolam · ATC N05CD08
14 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Italyprice
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Statesprice
Price per daily dose
What a daily dose of midazolam costs, country by country.
Normalised to the WHO defined daily dose (5 mg), the median price runs from $0.55 in Switzerland to $16.47 in Spain — a ×30 gap.
- 3 markets with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Midazolam · price per daily dose (5 mg)
USD · FX 28 Sept 2026
- ES Spain$16.47
- FI Finland$4.74
- CH Switzerland$0.55
The record
At a glance
HPRA (Ireland)- Active substance
- Midazolam
- Manufacturer
- Laboratorios Lesvi, S.L.
- Country
- Ireland (IE)
- ATC code
- N05CD08
- ATC class
- Midazolam
- Defined daily dose
- 5 mg, N
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/11/709/002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
316 interactions on record for midazolam.
Graded by severity as the source publishes them — 9 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Midazolam · interactions on record
316 records
- 9 severe
- 156 moderate
- 34 minor
- 57 info
Most severe, free to view
- KetoconazoleH02CA03severe
- KetoconazoleJ02AB02severe
- FluconazoleJ02AC01severe
- Darunavir and cobicistatJ05AR14severe
60 more interactions with mechanism and management, from a commercially licensed source.
Sign in to check- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
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 syringesDE Pharmaceuticals
- SwedenBUCCOLAM 5 mg MunhålelösningNeuraxpharm Pharmaceuticals S.L.
- FinlandBUCCOLAMNeuraxpharm Pharmaceuticals S.L.
- IcelandBuccolamNeuraxpharm Pharmaceuticals S.L.
- PolandEpistatusSERB S.A.
- BelgiumBuccolam 5 mgNeuraxpharm Pharmaceuticals
- NetherlandsMidazolam Xiromed 5 mg oplossing voor oromucosaal gebruikMedical Valley Invest AB
- United StatesmidazolamSagent Pharmaceuticals
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
- 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 HPRA (Ireland). 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/bf373492-2cb1-48ba-a1aa-68be9fc5bc21 GET /v1/drugs/bf373492-2cb1-48ba-a1aa-68be9fc5bc21?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.
{
"form": "Oromucosal solution",
"routes": [
"Oromucosal use"
],
"source": "hpra",
"atc_all": [
"N05CD",
"N05CD08"
],
"strength": null,
"pa_number": "EU/1/11/709/002",
"substances": [
"Midazolam"
],
"legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "26/10/2011",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}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.