In other countries
The same active substances on other registers, the same brand first.
- MIDAZOLAM B. BRAUN 1 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION EFGSpain · 1,000 mg · solución inyectable y para perfusión · B. Braun Melsungen AgSame form
- MIDAZOLAM B. BRAUN 5 mg/ml SOLUCION PARA INYECCION/PERFUSION EFGSpain · 5,000 mg · solución inyectable y para perfusión · B. Braun Melsungen AgSame form
- Midazolam Normon 1 MG/ML Solución Inyectable y Para Perfusión EfgSpain · 5 mg · solución inyectable · Laboratorios Normon S.A.Same form
- Dormicum 15 mg/3 ml otopina za injekciju/infuzijuCroatia · otopina za injekciju/infuziju · Cheplapharm Arzneimittel GmbH, Ziegelhof 24, Greifswald, NjemačkaSame form
- Midazolam B. Braun 1 mg/ml otopina za injekciju/infuzijuCroatia · Otopina za injekciju / infuziju · B. Braun Adria d.o.o., Hondlova 2/9, Zagreb, HrvatskaSame form
- Midazolam hameln 5 mg/ml otopina za injekciju/infuzijuCroatia · Otopina za injekciju / infuziju · hameln pharma GmbH, Inselstrasse 1, Hameln, NjemačkaSame form
- Dormicum 5 mg/ml oplossing voor injectieNetherlands · Oplossing voor injectie · CHEPLAPHARM Arzneimittel GmbHSame form
- Midazolam Accord 1 mg/ml oplossing voor injectie/infusie in voorgevulde spuitNetherlands · Oplossing voor injectie of infusie · Accord Healthcare B.V.Same form
- Midazolam Accord 1 mg/ml, oplossing voor injectie of infusieNetherlands · Oplossing voor injectie of infusie · Accord Healthcare B.V.Same form
- Midazolam-BaxterNew Zealand · Inj 5 mg per ml, 3 ml ampouleSame form
- Midazolam-BaxterNew Zealand · Inj 5 mg per ml, 3 ml ampouleSame form
- Midazolam-BaxterNew Zealand · Inj 1 mg per ml, 5 ml ampouleSame form
- MIDAZOLAM SUN 1 mg/mlRomania · 1 mg/ml · sol. inj./ perf. in seringa preumpluta · Sun Pharmaceutical Industries Europe B.V.Same form
- MIDAZOLAM SUN 2 mg/mlRomania · 1mg/ml · sol. inj./ perf. in seringa preumpluta · Sun Pharmaceutical Industries Europe B.V.Same form
- Dormicum®Serbia · 15mg/3mL · rastvor za injekciju · Clinres Farmacija D.O.O. BeogradSame form
- Dormicum®Serbia · 5mg/5mL · rastvor za injekciju · Clinres Farmacija D.O.O. BeogradSame form
- Dormicum®Serbia · 5mg/5mL · rastvor za injekciju · Clinres Farmacija D.O.O. BeogradSame form
- Hikma Midazolam 5MG-1ML AmpoulesSaudi Arabia · Hikma FarmaceuticaSame form
- Hikma Midazolam 5MG-1ML AmpoulesSaudi Arabia · Hikma FarmaceuticaSame form
- Midazolam- Hameln 1MG-ML Solu. for InjSaudi Arabia · Hameln PharmaceuticalsSame form
- DOMI INJECTION 5 mg/mlSingapore · 5 mg/ml · injection · Duopharma (Singapore) Pte LTDSame form
- DORMICUM INJECTION 15 mg/3 mlSingapore · 5 mg/ml · injection · DKSH Singapore Pte. LTD.Same form
- DORMICUM INJECTION 5 mg/5 mlSingapore · 1 mg/ml · injection · DKSH Singapore Pte. LTD.Same form
- Midazolam HydrochlorideUnited States · 1MG BASE/ML, 5MG BASE/ML · injectable · HikmaSame form
- Midazolam Hydrochloride Preservative FreeUnited States · 1MG BASE/ML, 5MG BASE/ML · injectable · Onesource SpecialtySame form
- Midozalam HydrochlorideUnited States · 1MG BASE/ML, 5MG BASE/ML · injectable · Onesource SpecialtySame form
- cloridrato de midazolamBrazil · Newcom Farmaceutica Ltda.Same substance
- DormireBrazil · Cristália Produtos Químicos Farmacêuticos Ltda.Same substance
- DormiumBrazil · União Química Farmacêutica Nacional S/ASame substance
- BuccolamCanada · 10 MG / 2 ML · Solution · Neuraxpharm Pharmaceuticals, S.L.Same substance
- BuccolamCanada · 2.5 MG / 0.5 ML · Solution · Neuraxpharm Pharmaceuticals, S.L.Same substance
- BuccolamCanada · 5 MG / 1 ML · Solution · Neuraxpharm Pharmaceuticals, S.L.Same substance
- BuccolamEuropean Union · Neuraxpharm Pharmaceuticals S.L.Same substance
- OmforroEuropean Union · Regulatory Pharma Net S.r.l.Same substance
- TuzodiEuropean Union · Regulatory Pharma Net S.r.l.Same substance
- Dormicum Ampoules 5MG/5MLTaiwan · 注射劑 · 台灣大昌華嘉股份有限公司Same substance
- Dormicum Ampoules 5MG/MLTaiwan · 注射劑 · 台灣大昌華嘉股份有限公司Same substance
- Dormicum Film-Coated Tablets 7.5MGTaiwan · 膜衣錠 · 台灣大昌華嘉股份有限公司Same substance
Packs
| Pack | Code | Status |
|---|---|---|
| 5 MG/1ML SOLUZIONE INIETTABILE> 1 FIALA IN VETRO DA 1 ML | 037263011 | Autorizzata |
| 5 MG/1 ML SOLUZIONE INIETTABILE - 5 FIALE IN VETRO DA 1 ML | 037263023 | Autorizzata |
| 5 MG/1 ML SOLUZIONE INIETTABILE - 10 FIALE IN VETRO DA 1 ML | 037263035 | Autorizzata |
| 15 MG/3 ML SOLUZIONE INIETTABILE - 1 FIALA IN VETRO DA 3 ML | 037263047 | Autorizzata |
| 15 MG/3 ML SOLUZIONE INIETTABILE - 5 FIALE IN VETRO DA 3 ML | 037263050 | Autorizzata |
| 15 MG/3 ML SOLUZIONE INIETTABILE - 10 FIALE IN VETRO DA 3 ML | 037263062 | Autorizzata |
Documents
The official texts, at the regulator.
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
Agenzia Italiana del Farmaco (AIFA), Italy
Agenzia Italiana del Farmaco (AIFA); https://drive.aifa.gov.it/farmaci/confezioni_fornitura.csv; HTTP Last-Modified Mon, 12 Oct 2026 23:02:44 GMT; acquired 2026-10-13T17:21:16.224007+00:00; native fields retained, source identifier and role projections are adaptations.
Licence: CC BY 4.0; AIFA published open-data catalog · Added 13 Oct 2026
Report an error or request removalCorrections from the holder or the register are welcome.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Active substance
- Midazolam
- Dosage form
- Soluzione iniettabile
- Register
- Italy (AIFA)
- Status
- Authorised
- Status in the register
- Autorizzata
- Registration
- AIC 037263
- Marketing authorisation holder
- Fisiopharma S.R.L.
- ATC code
- N05CD08
- Group
- Nervous system
- Procedure
- Procedura Nazionale
- Supply
- Medicinali soggetti a prescrizione medica limitativa, utilizzabili esclusivamente in ambiente ospedaliero o in una struttura ad esso assimilabile