Is Midazolam registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 8 valid registrations of Midazolam, including DORMICUM 15MG-3ML AMP. (5 mg/ml, Solution for injection, SAR 55.70); HIKMA MIDAZOLAM 5MG-1ML AMPOULES (5 mg/ml, Solution for injection, SAR 36.90); MODZAL 15MG/3ML INJECTION (5 mg/ml, Solution for injection, SAR 36.90); MODZAL 5MG/5ML INJECTION (1 mg/ml, Solution for injection, SAR 26.20); Midathetic (5 mg/ml, Solution for injection, SAR 14.25).

Is Midazolam approved by the US FDA?

Drugs@FDA lists 46 application product lines for Midazolam, including MIDAZOLAM HYDROCHLORIDE (Prescription); MIDAZOLAM HYDROCHLORIDE (Prescription); MIDAZOLAM HYDROCHLORIDE (Prescription); MIDAZOLAM HYDROCHLORIDE (Prescription); MIDAZOLAM HYDROCHLORIDE (Prescription).

Is Midazolam authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Midazolam: Buccolam.

Is Midazolam on the WHO Model List of Essential Medicines?

Yes — 5.1.1. Antiseizure medicines (core list): Therapeutic equivalent to lorazepam for Status epilepticus; Status epilepticus.

Are there safety signals or safety updates for Midazolam?

EMA PRAC: 1 entry; US FDA: 2 entries (latest 2026-05-07).

Active substance

Midazolam

SFDA 13
US FDA 46
EMA 3
Health Canada 14
US price lines 7
NHS prices 13
WHO EML 3
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DORMICUM 15MG-3ML AMP.	5 mg/ml	Solution for injection · Parenteral use	5 Ampoule	SAR 55.70	Generic · Prescription	CHEPLAPHARM Arzneimittel GmbH	Valid
HIKMA MIDAZOLAM 5MG-1ML AMPOULES	5 mg/ml	Solution for injection · Parenteral use	5 Ampoule	SAR 36.90	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
MODZAL 15MG/3ML INJECTION	5 mg/ml	Solution for injection · Parenteral use	5 Vial	SAR 36.90	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
MODZAL 5MG/5ML INJECTION	1 mg/ml	Solution for injection · Parenteral use	10 Vial	SAR 26.20	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Midathetic	5 mg/ml	Solution for injection · Intravenous use	3 Ampoule	SAR 14.25	Generic · Prescription	Amoun Pharmaceutical Company	Valid
Midazolam Kalceks	1 mg/ml	Solution for injection/infusion · Intramuscular and intravenous use	10 Ampoule	SAR 26.20	Generic · Prescription	AS Kalceks	Valid
Midazolam Kalceks	5 mg/ml	Solution for injection/infusion · Intramuscular and intravenous use	10 Ampoule	SAR 26.20	Generic · Prescription	AS Kalceks	Valid
Midazolam Kalceks	5 mg/ml	Solution for injection/infusion · Intramuscular and intravenous use	10 Ampoule	SAR 78.60	Generic · Prescription	AS Kalceks	Valid
DORMICUM 5MG-1ML AMP.	5 mg/ml	Solution for injection · Parenteral use	10 Ampoule	SAR 43.30	NCE · Prescription	ROCHE	Withdrawn by MAH · Not Marketed
DORMICUM 5MG-5ML AMP.	1 mg/ml	Solution for injection · Parenteral use	10 Ampoule	SAR 43.30	NCE · Prescription	ROCHE	Withdrawn by MAH · Not Marketed
MIDAZOLAM- HAMELN 1MG-ML SOLU. FOR INJ	1 mg/ml	Solution · Parenteral use	10 Ampoule	SAR 22.60	Generic · Prescription	HAMELN PHARMACEUTICALS	Withdrawn by MAH · Not Marketed
MIDAZOLAM- HAMELN 5MG-ML SOLU. FOR INJ	5 mg/ml	Solution · Parenteral use	10 Ampoule	SAR 56.45	Generic · Prescription	HAMELN PHARMACEUTICALS	Withdrawn by MAH · Not Marketed
MIDAZOLAM- HAMELN 5MG-ML SOLU. FOR INJ	5 mg/ml	Solution · Parenteral use	10 Ampoule	SAR 22.60	Generic · Prescription	HAMELN PHARMACEUTICALS	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ACUTE MANIA; ANESTHESIA; ANXIETY DISORDERS; BIPOLAR II DISORDER; HUNTINGTON'S DISEASE-TICS; POSTOPERATIVE NAUSEA AND VOMITING; SCHIZOPHRENIA; STATUS EPILEPTICUS; VERTIGO - MOTION SICKNESS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML; EQ 1MG BASE/ML	injectable · injection	FRESENIUS KABI USA	Prescription	20 Jun 2000
MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML; EQ 5MG BASE/ML	injectable · injection	HIKMA PHARMS	Prescription	20 Jun 2000
MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML; EQ 5MG BASE/ML	injectable · injection	HOSPIRA	Prescription	20 Jun 2000
MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML; EQ 5MG BASE/ML	injectable · injection	HIKMA PHARMS	Prescription	20 Jun 2000
MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML; EQ 1MG BASE/ML	injectable · injection	HIKMA PHARMS	Prescription	20 Jun 2000
MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML; EQ 1MG BASE/ML	injectable · injection	HIKMA PHARMS	Prescription	23 Jun 2000
MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML; EQ 5MG BASE/ML	injectable · injection	RISING	Prescription	30 Jun 2000
MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	syrup · oral	HIKMA PHARMS	Prescription	30 Apr 2002
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML; EQ 5MG BASE/ML	injectable · injection	HOSPIRA	Prescription	22 Jul 2002
MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	syrup · oral	PADAGIS US	Prescription	2 May 2005
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML; EQ 5MG BASE/ML	injectable · injection	ONESOURCE SPECIALTY	Prescription	29 Nov 2010
MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML; EQ 5MG BASE/ML	injectable · injection	ONESOURCE SPECIALTY	Prescription	4 May 2011
MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	injectable · injection	GLAND PHARMA LTD	Prescription	25 Jan 2012
MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	injectable · injection	GLAND PHARMA LTD	Prescription	29 Feb 2012
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML; EQ 5MG BASE/ML	injectable · injection	FRESENIUS KABI USA	Prescription	22 Aug 2014
NAYZILAM	5MG/SPRAY	spray · nasal	UCB INC	Prescription	17 May 2019
MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML; EQ 5MG BASE/ML	injectable · injection	HIKMA PHARMS	Prescription	11 Dec 2020
MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML); 100MG/100ML (1MG/ML)	solution · intravenous	INFORLIFE	Prescription	22 Mar 2021
MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	solution · intramuscular	RAFA LABS LTD	Prescription	8 Aug 2022
MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML); 100MG/100ML (1MG/ML)	solution · intravenous	HIKMA	Prescription	17 Apr 2023
MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML; EQ 5MG BASE/ML	injectable · injection	MICRO LABS	Prescription	21 Aug 2023
MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML); 100MG/100ML (1MG/ML)	solution · intravenous	GLAND	Prescription	12 Aug 2024
MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML); 100MG/100ML (1MG/ML)	solution · intravenous	B BRAUN MEDICAL	Prescription	1 May 2025
VERSED	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	HLR	Discontinued	20 Dec 1985
VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	syrup · oral	ROCHE	Discontinued	15 Oct 1998

21 more — full table

EMA European Union — centrally authorised medicines

Buccolam Neuraxpharm Pharmaceuticals S.L. · Authorised · authorised 4 Sep 2011 · ATC N05CD08

Therapeutic indication (EMA)

Treatment of prolonged, acute, convulsive seizures in infants from 3 months to adults.BUCCOLAM must only be used by parents/carers where the patient has been diagnosed to have epilepsy.For infants between 3-6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available. See section 4.2.

Omforro Regulatory Pharma Net S.r.l. · Application withdrawn · ATC N05CD08

Therapeutic indication (EMA)

Conscious sedation before and during diagnostic or therapeutic procedures with or without local anaesthesia and premedication before induction of anaesthesia.

Tuzodi Regulatory Pharma Net S.r.l. · Application withdrawn · ATC N05CD08

Therapeutic indication (EMA)

Treatment of prolonged, acute, convulsive seizures in adults, adolescents, children and toddlers (from 2 years of age).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BUCCOLAM	02559579	2.5 MG / 0.5 ML	SOLUTION · BUCCAL	NEURAXPHARM PHARMACEUTICALS, S.L.
BUCCOLAM	02559587	5 MG / 1 ML	SOLUTION · BUCCAL	NEURAXPHARM PHARMACEUTICALS, S.L.
BUCCOLAM	02559595	7.5 MG / 1.5 ML	SOLUTION · BUCCAL	NEURAXPHARM PHARMACEUTICALS, S.L.
BUCCOLAM	02559609	10 MG / 2 ML	SOLUTION · BUCCAL	NEURAXPHARM PHARMACEUTICALS, S.L.
MIDAZOLAM INJECTION	02240285	1 MG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	SANDOZ CANADA INCORPORATED
MIDAZOLAM INJECTION	02240286	5 MG / ML	SOLUTION · INTRAMUSCULAR; INTRAVENOUS	SANDOZ CANADA INCORPORATED
MIDAZOLAM INJECTION USP	02382342	1 MG / ML	SOLUTION · INTRAMUSCULAR; INTRAVENOUS	PFIZER CANADA ULC
MIDAZOLAM INJECTION USP	02382350	5 MG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	PFIZER CANADA ULC
MIDAZOLAM INJECTION USP	02382377	1 MG / ML	SOLUTION · INTRAMUSCULAR; INTRAVENOUS	PFIZER CANADA ULC
MIDAZOLAM INJECTION USP	02382385	5 MG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	PFIZER CANADA ULC
MIDAZOLAM INJECTION USP	02498022	1 MG / ML	SOLUTION · INTRAVENOUS	STERINOVA INC.
MIDAZOLAM INJECTION USP	02553104	1 MG / ML	SOLUTION · INTRAVENOUS	HIKMA CANADA LIMITED
MIDAZOLAM INJECTION, USP	02242904	1 MG / ML	SOLUTION · INTRAMUSCULAR; INTRAVENOUS	FRESENIUS KABI CANADA LTD
MIDAZOLAM INJECTION, USP	02242905	5 MG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	FRESENIUS KABI CANADA LTD

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	MIDAZOLAM HCL 10 MG/2 ML VIAL	$0.56523	per ML	23 Sep 2026
US NADAC	MIDAZOLAM HCL 10 MG/2 ML VIAL	$0.50532	per ML	18 Feb 2026
US NADAC	MIDAZOLAM HCL 2 MG/2 ML VIAL	$0.23341	per ML	23 Sep 2026
US NADAC	MIDAZOLAM HCL 2 MG/ML SYRUP	$0.61771	per ML	23 Sep 2026
US NADAC	MIDAZOLAM HCL 5 MG/ML VIAL	$1.22585	per ML	23 Sep 2026
US NADAC	MIDAZOLAM HCL 50 MG/10 ML VIAL	$0.38167	per ML	23 Sep 2026
US NADAC	NAYZILAM 5 MG NASAL SPRAY	$327.04771	per EA	23 Sep 2026
NHS Drug Tariff	Midazolam 10mg/1ml oromucosal solution pre-filled oral syringes sugar free	£45.76	1 unit dose	1 Oct 2026
NHS Drug Tariff	Midazolam 10mg/2ml oromucosal solution pre-filled oral syringes sugar free	£91.50	4 unit dose	1 Oct 2026
NHS Drug Tariff	Midazolam 10mg/2ml solution for injection ampoules	£5.28	10 ampoule	1 Oct 2026
NHS Drug Tariff	Midazolam 10mg/5ml solution for injection ampoules	£9.80	10 ampoule	1 Oct 2026
NHS Drug Tariff	Midazolam 2.5mg/0.25ml oromucosal solution pre-filled oral syringes sugar free	£43.75	1 unit dose	1 Oct 2026
NHS Drug Tariff	Midazolam 2.5mg/0.5ml oromucosal solution pre-filled oral syringes sugar free	£82.00	4 unit dose	1 Oct 2026
NHS Drug Tariff	Midazolam 2mg/2ml solution for injection ampoules	£9.30	10 ampoule	1 Oct 2026
NHS Drug Tariff	Midazolam 50mg/10ml solution for injection ampoules	£33.00	10 ampoule	1 Oct 2026
NHS Drug Tariff	Midazolam 5mg/0.5ml oromucosal solution pre-filled oral syringes sugar free	£43.75	1 unit dose	1 Oct 2026
NHS Drug Tariff	Midazolam 5mg/1ml oromucosal solution pre-filled oral syringes sugar free	£85.50	4 unit dose	1 Oct 2026
NHS Drug Tariff	Midazolam 5mg/5ml solution for injection ampoules	£13.59	10 ampoule	1 Oct 2026
NHS Drug Tariff	Midazolam 7.5mg/0.75ml oromucosal solution pre-filled oral syringes sugar free	£43.75	1 unit dose	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

5.1.1. Antiseizure medicines · core
Therapeutic equivalent to lorazepam for Status epilepticus; Status epilepticus
Parenteral > General injections > unspecified: 1 mg per mL in 5 mL vial (for buccal administration); 5 mg per mL in 1 mL vial (for buccal administration); 5 mg per mL in 3 mL vial (for buccal administration) | Local > Buccal > Solution: 5 mg per mL in 0.5 mL pre-filled syringe (for oromucosal administration); 5 mg per mL in 1 mL pre-filled syringe (for oromucosal administration); 5 mg per mL in 1.5 mL pre-filled syringe (for oromucosal administration); 5 mg per mL in 2 mL pre-filled syringe (for oromucosal administration); 10 mg per mL in 0.25 mL pre-filled syringe (for oromucosal administration); 10 mg per mL in 0.5 mL pre-filled syringe (for oromucosal administration); 10 mg per mL in 0.75 mL pre-filled syringe; 10 mg per mL in 1 mL pre-filled syringe (for oromucosal administration)
2.3. Medicines for other common symptoms in palliative care · core
Palliative care
Oral > Liquid: 2 mg per mL (EMLc) | Parenteral > General injections > unspecified: 1 mg per mL in 5 mL vial; 5 mg per mL in 1 mL vial; 5 mg per mL in 3 mL vial | Local > Buccal > Solution:; 5 mg per mL in 0.5 mL pre-filled syringe (for oromucosal administration); 5 mg per mL in 1 mL pre-filled syringe (for oromucosal administration); 5 mg per mL in 1.5 mL pre-filled syringe (for oromucosal administration); 5 mg per mL in 2 mL pre-filled syringe (for oromucosal administration); 10 mg per mL in 0.25 mL pre-filled syringe (for oromucosal administration); 10 mg per mL in 0.5 mL pre-filled syringe (for oromucosal administration); 10 mg per mL in 0.75 mL pre-filled syringe (for oromucosal administration); 10 mg per mL in 1 mL pre-filled syringe (for oromucosal administration) | Oral > Solid > dosage form: 7.5 mg (EML); 15 mg (EML)
1.3. Preoperative medication and sedation for short-term procedures · core
Sedative-hypnotic and anxiolytic drugs
Parenteral > General injections > IV: 1 mg per mL in 5 vial; 5 mg per mL in 1 mL vial; 5 mg per mL in 3 mL vial | Oral > Liquid: 2 mg per mL (EMLc) | Oral > Solid > dosage form: 15 mg (EML); 7.5 mg (EML)

Safety signals and safety-related labeling changes

EMA PRAC 7 May 2026 PRAC signal: Miscarriage associated with in utero exposure to benzodiazepines (including fixed-dose combinations)
Action for MAH: update of the product information: No
US FDA 13 Jan 2023 NAYZILAM — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 13 Jan 2023 SEIZALAM — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for midazolam →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.