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Medicines
Spain
Midazolam

AEMPS 2021

Midazolam

Oroxelam 10 MG Solucion Bucal

10 mg solución bucalSpainMarketedAuthorised 9 Feb 2021

Product informationAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

OroxelamItaly · Soluzione orale/per mucosa orale · Exeltis Italia S.R.L.Same brand
Dormicum 15 mg filmom obložene tableteCroatia · filmom obložena tableta · Cheplapharm Arzneimittel GmbH, Ziegelhof 24, Greifswald, NjemačkaSame form
Dormicum 15 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · CHEPLAPHARM Arzneimittel GmbHSame form
Dormicum 7,5 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · CHEPLAPHARM Arzneimittel GmbHSame form
Flormidal®Serbia · 15mg · film tableta · Galenika Ad BeogradSame form
DORMICUM TABLET 15 mgSingapore · 15 mg · tablet, film coated · DKSH Singapore Pte. LTD.Same form

More with the same substance on this register

Buccolam 10 MG Solucion BucalMidazolam · 5,00 mg · solución bucalSpain
Buccolam 2,5 MG Solucion BucalMidazolam · 5,00 mg · solución bucalSpain

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

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 · 7.5 MG / 1.5 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 15 mg/3 ml otopina za injekciju/infuzijuCroatia · otopina za injekciju/infuziju · Cheplapharm Arzneimittel GmbH, Ziegelhof 24, Greifswald, NjemačkaSame substance

🇭🇷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 substance

🇮🇹BuccolamItaly · Soluzione per mucosa orale · Neuraxpharm Pharmaceuticals, S.LSame substance

🇮🇹EpistatusItaly · Soluzione per mucosa orale · Serb S.A.Same substance

🇳🇱Buccolam 10mg/2ml, oplossing voor oromucosaal gebruikNetherlands · Oplossing voor oromucosaal gebruik · Laboratorios Lesvi S.L.Same substance

🇳🇿AnyNew Zealand · Oral liq 2 mg per mlSame substance

🇳🇿Midazolam-BaxterNew Zealand · Inj 5 mg per ml, 3 ml ampouleSame substance

🇳🇿Midazolam-BaxterNew Zealand · Inj 5 mg per ml, 3 ml ampouleSame substance

🇷🇴MIDAZOLAM SUN 1 mg/mlRomania · 1 mg/ml · sol. inj./ perf. in seringa preumpluta · Sun Pharmaceutical Industries Europe B.V.Same substance

🇷🇴MIDAZOLAM SUN 2 mg/mlRomania · 1mg/ml · sol. inj./ perf. in seringa preumpluta · Sun Pharmaceutical Industries Europe B.V.Same substance

🇷🇸Dormicum®Serbia · 5mg/5mL · rastvor za injekciju · Clinres Farmacija D.O.O. BeogradSame substance

🇷🇸Dormicum®Serbia · 15mg/3mL · rastvor za injekciju · Clinres Farmacija D.O.O. BeogradSame substance

🇸🇦Dormicum 15MG-3ML Amp.Saudi Arabia · CenexiSame substance

🇸🇦Dormicum 5MG-1ML Amp.Saudi Arabia · CenexiSame substance

🇸🇦Dormicum 5MG-5ML Amp.Saudi Arabia · CenexiSame substance

🇸🇬DOMI INJECTION 5 mg/mlSingapore · 5 mg/ml · injection · Duopharma (Singapore) Pte LTDSame substance

🇸🇬DORMICUM INJECTION 15 mg/3 mlSingapore · 5 mg/ml · injection · DKSH Singapore Pte. LTD.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

🇺🇸Midazolam HydrochlorideUnited States · 1MG BASE/ML, 5MG BASE/ML · injectable · HikmaSame substance

🇺🇸Midazolam HydrochlorideUnited States · 2MG BASE/ML · syrup · Padagis USSame substance

🇺🇸Midazolam Hydrochloride (Autoinjector)United States · 10MG BASE/0.7ML · solution · Rafa Labs LTDSame substance

Packs

Pack	Code	Status
OROXELAM 10 MG SOLUCION BUCAL, 4 jeringas precargadas para uso oral de 2 ml	730340
OROXELAM 10 MG SOLUCION BUCAL, 2 jeringas precargadas para uso oral de 2 ml	730811

Documents

The official texts, at the regulator.

Summary of product characteristicsAEMPS
Package leafletAEMPS
Register entryAEMPS

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 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
Strength: 10 mg
Dosage form: solución bucal
Route: Vía bucal (buccal use)
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 9 Feb 2021
Registration: 85756
Marketing authorisation holder: Exeltis Healthcare S.L.
Procedure: National, MRP or DCP
Supply: Medicamento Sujeto A Prescripción Médica. Psicótropos

AEMPS

Buccolam 5 MG Solucion BucalMidazolam · 5,00 mg · solución bucal🇪🇸Spain

AEMPSBuccolam 7,5 MG Solucion BucalMidazolam · 5,00 mg · solución bucal🇪🇸Spain

AEMPSDORMICUM 7,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA.Midazolam · 7,5 mg · comprimido🇪🇸Spain

AEMPSMIDAZOLAM B. BRAUN 1 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION EFGMidazolam · 1,000 mg · solución inyectable y para perfusión🇪🇸Spain

AEMPSMIDAZOLAM B. BRAUN 5 mg/ml SOLUCION PARA INYECCION/PERFUSION EFGMidazolam · 5,000 mg · solución inyectable y para perfusión🇪🇸Spain

AEMPSMidazolam Normon 1 MG/ML Solución Inyectable y Para Perfusión EfgMidazolam · 5 mg · solución inyectable🇪🇸Spain

AEMPSMidazolam Normon 5 MG/ML Solución Inyectable y Para Perfusión EfgMidazolam · 50 mg · solución inyectable🇪🇸Spain

AEMPSMidazolam Serraclinics 1 MG / ML Solución Inyectable y Para Perfusión EfgMidazolam · 5 mg · solución inyectable🇪🇸Spain

AEMPSMidazolam Serraclinics 5 MG/ML Solución Inyectable y Para Perfusión EfgMidazolam · 5 mg · solución inyectable🇪🇸Spain

AEMPSOroxelam 2,5 MG Solucion BucalMidazolam · 2,5 mg · solución bucal🇪🇸Spain