Midazolam
Sold as Sedolam, Dormicum, Midazolam hexal biotech, Midacum, Midanium, Midazolam PHARMC, Miloz, Midazolam safeline, Accord-midazolam, Midazolam b braun, Midazolam specpharm, Mizam ( ), Midazolam accord, Miranost, Midazolam nasal cipla, Pharma-q midazolam, Midazolam-cp, Zolamid, Sabax midazolam, Adco midazolam, SPEC midazolam
8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine
Drag to rotate. Structure from PubChem CID 4192.
Background
Registration
- Applicants
- 15
- Registrations
- 49
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Wildlife Pharmaceuticals (Pty) Ltd | Sedolam | 50 | 19/15 | S5 | None |
| Pharmaco Distribution (Pty) Ltd | Dormicum | 5 mg/5 ml, 7,5 mg, 15 mg/3 ml, 15 mg, 50 mg/10 ml | 270078, Q0286, R0123, T0207, Y0325 | S5 | None |
| Biotech Laboratories (Pty) Ltd3 of 5 cancelled | Midazolam hexal biotech, Mizam ( ) | 1 mg/ml 5 ml, 5 mg/1 ml, 5 mg/ml 5 ml, 5 mg/ml 10 ml, 15 mg/3 ml | 350321, 350322, 450847, 450848, 450849 | S5 | None |
| Oethmaan Biosims (Pty) Ltd | Midacum | 5 mg/ml, 15 mg/3 ml | 350323, 350324 | S5 | None |
| Cipla Medpro (Pty) Ltd3 of 5 cancelled | Midanium, Miranost, Midazolam nasal cipla | 5 mg/5 ML, 5 mg, 15 mg/3 ML, 50 mg/10 ml | 370023, 370024, 410909, 580059, 580060.059 | S5 | None |
| Pharmacorp (Pty) Ltd | Midazolam PHARMC | 50 mg/10 mL | 380190 | S5 | PIPIL |
| Gulf Drug Company (Pty) LtdCancelled | Miloz | 5, 15 | 410019, 410174 | S5 | None |
| Safeline Pharmaceuticals (Pty) LtdCancelled | Midazolam safeline | 15 mg -, 50 mg - | 420045, 420046 | S5 | None |
| Accord Healthcare (Pty) LtdCertificate held by Accord Healthcare (Pty) Ltd | Accord-midazolam, Midazolam accord | 1,0 mg, 5 mg/5 ml, 15 mg/3 ml, 50 mg/10 ml | 420327, 420328, 420329, 550375 | S5 | PIPIL |
| B Braun Medical (Pty) LtdCancelled | Midazolam b braun | 1 mg/ml, 5 mg/ml | 430171, 430172 | S5 | None |
| Specpharm (Pty) Ltd | Midazolam specpharm, SPEC midazolam | 5 mg/5 ml, 5 mg/ml, 15 mg/3 ml, 50 mg/10 ml | 440715, 440716, 440717, 440718, A400760 | S5 | None |
| Pharma-q Holdings (Pty) Ltd | Pharma-q midazolam | 5 mg/5 ml, 15 mg/3 ml, 50 mg/10 ml | A380564, A380565, A380566 | S5 | None |
| Pharmaplan (Pty) LtdCancelled | Midazolam-cp | 5 mg/5 ML, 15 mg/3 ML, 50 mg/10 ML | A390184, A390185, A390186 | S5 | None |
| Dezzo Trading 392 (Pty) Ltd | Zolamid | 5 mg/5 ml, 15 mg/3 ML, 50 mg/10 ml | A400054, A400055, A400056 | S5 | None |
| Adcock Ingram Critical Care (Pty) Ltd | Sabax midazolam, Adco midazolam | 5 mg/5 ml, 15 mg/3 ml, 50 mg/10 ml | A400569, A400570, A400571, A400753, A400754, A400755 | S5 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Sedolam 50 EACH 1,0 ml SOLUTION CONTAINS MIDAZOLAM 50,0 mg | 50 | 19/1519/1.4.1/15 | Registered | S5 | None |
| Dormicum 7,5 MG EACH TABLET CONTAINS MIDAZOLAM 7,5 mg | 7,5 mg | 27007827/2.2/0078 | Registered | S5 | None |
| Midazolam hexal 5 mg/1 ML biotech EACH 1,0 ml SOLUTION CONTAINS MIDAZOLAM 5,0 mg | 5 mg/1 ml | 35032135/2.2/0321 | Registered | S5 | None |
| Midazolam hexal 15 mg/3 ML biotech EACH 3,0 ml SOLUTION CONTAINS MIDAZOLAM 15,0 mg | 15 mg/3 ml | 35032235/2.2/0322 | Registered | S5 | None |
| Midacum 5 mg/ml EACH 1,0 ml SOLUTION CONTAINS MIDAZOLAM 5,0 mg | 5 mg/ml | 35032335/2.2/0323 | Registered | S5 | None |
| Midacum 15 mg/3 ML EACH 3,0 ml SOLUTION CONTAINS MIDAZOLAM 15,0 mg | 15 mg/3 ml | 35032435/2.2/0324 | Registered | S5 | None |
| Midanium 5 mg/5 ML EACH 1,0 ml SOLUTION CONTAINS MIDAZOLAM 1.0 mg | 5 mg/5 ML | 37002337/2.2/0023 | Cancelled | S5 | None |
| Midanium 15 mg/3 ML EACH 1,0 ml SOLUTION CONTAINS MIDAZOLAM 5,0 mg | 15 mg/3 ML | 37002437/2.2/0024 | Cancelled | S5 | None |
| Midazolam 50 mg/10 ML PHARMC EACH 10,0 ml AMPOULE CONTAINS MIDAZOLAM 50,0 mg | 50 mg/10 mLSolution for injection or infusion. | 38019038/2.2/0190Approved 13 August 2025 | Registered | S5 | PIPIL |
| Miloz 5 EACH 5,0 ml SOLUTION CONTAINS MIDAZOLAM HYDROCHLORIDE EQUIVALENT TO MIDAZOLAM 5,0 mg | 5 | 41001941/2.2/0019 | Cancelled | S5 | None |
| Miloz 15 EACH 3,0 ml SOLUTION CONTAINS MIDAZOLAM HYDROCHLORIDE EQUIVALENT TO MIDAZOLAM 15,0 mg | 15 | 41017441/2.2/0174 | Cancelled | S5 | None |
| Midanium 50 mg/10 ML EACH 10,0 ml SOLUTION CONTAINS MIDAZOLAM HYDROCHLORIDE EQUIVALENT TO MIDAZOLAM 50,0 mg | 50 mg/10 ml | 41090941/2.2/0909 | Cancelled | S5 | None |
| Midazolam - safeline 15 MG EACH 3,0 ml AMPOULE CONTAINS MIDAZOLAM HYDROCHLORIDE EQUIVALENT TO MIDAZOLAM 15,0 mg | 15 mg - | 42004542/2.2/0045 | Cancelled | S5 | None |
| Midazolam - safeline 50 MG EACH 10,0 ml AMPOULE CONTAINS MIDAZOLAM HYDROCHLORIDE EQUIVALENT TO MIDAZOLAM 50,0 mg | 50 mg - | 42004642/2.2/0046 | Cancelled | S5 | None |
| Accord-midazolam 15 mg/3 ML EACH 3,0 ml SOLUTION CONTAINS :MIDAZOLAM 15,0 mg | 15 mg/3 ml | 42032742/2.2/0327 | Registered | S5 | None |
| Accord-midazolam 50 mg/10 ML EACH 10,0 ml SOLUTION CONTAINS: MIDAZOLAM 50,0 mg | 50 mg/10 ml | 42032842/2.2/0328 | Registered | S5 | None |
| Accord-midazolam 5 mg/5 ML EACH 5,0 ml SOLUTION CONTAINS: MIDAZOLAM 5,0 mg | 5 mg/5 ml | 42032942/2.2/0329 | Registered | S5 | None |
| Midazolam b braun 1 mg/ml EACH 1,0 ml AMPOULE CONTAINS MIDAZOLAM 1,0 mg | 1 mg/ml | 43017143/2.2/0171 | Cancelled | S5 | None |
| Midazolam b braun 5 mg/ml EACH 3,0 ml AMPOULE CONTAINS MIDAZOLAM 15,0 mg | 5 mg/ml | 43017243/2.2/0172 | Cancelled | S5 | None |
| Midazolam specpharm 5 mg/5 ML EACH 5,0 ml AMPOULE CONTAINS MIDAZOLAM 5,0 mg | 5 mg/5 ml | 44071544/2.2/0715 | Registered | S5 | None |
| Midazolam specpharm 5 mg/ml EACH 1,0 ml AMPOULE CONTAINS MIDAZOLAM 5,0 mg | 5 mg/ml | 44071644/2.2/0716 | Registered | S5 | None |
| Midazolam specpharm 15 mg/3 ML EACH 3,0 ml AMPOULE CONTAINS MIDAZOLAM 15,0 mg | 15 mg/3 ml | 44071744/2.2/0717 | Registered | S5 | None |
| Midazolam specpharm 50 mg/10 ML EACH 10,0 ml AMPOULE CONTAINS MIDAZOLAM 50,0 mg | 50 mg/10 ml | 44071844/2.2/0718 | Registered | S5 | None |
| Mizam 1 mg/ml (5 ml) EACH 5,0 ml SOLUTION CONTAINS MIDAZOLAM 5,0 mg | 1 mg/ml 5 ml | 45084745/2.2/0847 | Cancelled | S5 | None |
| Mizam 5 mg/ml (5 ml) EACH 5,0 ml SOLUTION CONTAINS MIDAZOLAM 25,0 mg | 5 mg/ml 5 ml | 45084845/2.2/0848 | Cancelled | S5 | None |
| Mizam 5 mg/ml (10 ml) EACH 10,0 ml SOLUTION CONTAINS MIDAZOLAM 50,0 mg | 5 mg/ml 10 ml | 45084945/2.2/0849 | Cancelled | S5 | None |
| Midazolam 1 mg/ml accord EACH 1,0 ml SOLUTION CONTAINS MIDAZOLAM 1,0 mg | 1,0 mgSolution for injection/ infusion | 55037555/2.2/0375Approved 13 September 2022 | Registered | S5 | PIPIL |
| Miranost EACH SINGLE DOSE NASAL SPRAY CONTAINS MIDAZOLAM 5,0 mg | Not listed | 58005958/2.5/0059 | Registered | S5 | None |
| Midazolam 5 MG nasal spray cipla EACH SINGLE DOSE NASAL SPRAY CONTAINS MIDAZOLAM 5,0 mg | 5 mgSpray | 580060.05958/2.5/0060.059 | Registered | S5 | None |
| Pharma-q midazolam injection 5 mg/5 ML EACH AMPOULE CONTAINS MIDAZOLAM HYDROCHLORIDE EQUIVALENT TO MIDAZOLAM 5,0 mg | 5 mg/5 mlInjection | A380564A38/2.2/0564 | Registered | S5 | None |
| Pharma-q midazolam injection 15 mg/3 ML EACH AMPOULE CONTAINS MIDAZOLAM HYDROCHLORIDE EQUIVALENT TO MIDAZOLAM 15,0 mg | 15 mg/3 mlInjection | A380565A38/2.2/0565 | Registered | S5 | None |
| Pharma-q midazolam injection 50 mg/10 ML EACH 10,0 ml AMPOULE CONTAINS MIDAZOLAM HYDROCHLORIDE EQUIVALENT TO MIDAZOLAM 50,0 mg | 50 mg/10 mlInjection | A380566A38/2.2/0566 | Registered | S5 | None |
| Midazolam-cp 5 mg/5 ML EACH 5,0 ml AMPOULE CONTAINS MIDAZOLAM 5,0 mg | 5 mg/5 ML | A390184A39/2.2/0184 | Cancelled | S5 | None |
| Midazolam-cp 15 mg/3 ML EACH 3,0 ml AMPOULE CONTAINS MIDAZOLAM 15,0 mg | 15 mg/3 ML | A390185A39/2.2/0185 | Cancelled | S5 | None |
| Midazolam-cp 50 mg/10 ML EACH 10,0 ml AMPOULE CONTAINS MIDAZOLAM 50,0 mg | 50 mg/10 ML | A390186A39/2.2/0186 | Cancelled | S5 | None |
| Zolamid 5 mg/5 ML EACH 5,0 ml SOLUTION CONTAINS MIDAZOLAM 5,0 mg | 5 mg/5 ml | A400054A40/2.2/0054 | Registered | S5 | None |
| Zolamid 15 mg/3 ML EACH 3,0 ml SOLUTION CONTAINS MIDAZOLAM 15,0 mg | 15 mg/3 ML | A400055A40/2.2/0055 | Registered | S5 | None |
| Zolamid 50 mg/10 ML EACH 10,0 ml SOLUTION CONTAINS MIDAZOLAM 50,0 mg | 50 mg/10 ml | A400056A40/2.2/0056 | Registered | S5 | None |
| Sabax midazolam injection 5 mg/5 ML EACH 5,0 ml AMPOULE CONTAINS MIDAZOLAM 5,0 mg | 5 mg/5 mlInjection | A400569A40/2.2/0569 | Registered | S5 | None |
| Sabax midazolam injection 15 mg/3 ML EACH 3,0 ml AMPOULE CONTAINS MIDAZOLAM 15,0 mg | 15 mg/3 mlInjection | A400570A40/2.2/0570 | Registered | S5 | None |
| Sabax midazolam injection 50 mg/10 ML EACH 10,0 ml AMPOULE CONTAINS MIDAZOLAM 50,0 mg | 50 mg/10 mlInjection | A400571A40/2.2/0571 | Registered | S5 | None |
| Adco midazolam injection 5 mg/5 ML EACH 5,0 ml SOLUTION CONTAINS MIDAZOLAM 5,0 mg | 5 mg/5 mlInjection | A400753A40/2.2/0753 | Registered | S5 | None |
| Adco midazolam injection 15 mg/3 ML EACH 3,0 ml SOLUTION CONTAINS :MIDAZOLAM 15,0 mg | 15 mg/3 mlInjection | A400754A40/2.2/0754 | Registered | S5 | None |
| Adco midazolam injection 50 mg/10 ML EACH 10,0 ml SOLUTION CONTAINS: MIDAZOLAM 50,0 mg | 50 mg/10 mlInjection | A400755A40/2.2/0755 | Registered | S5 | None |
| SPEC midazolam EACH 3,0 ml AMPOULE CONTAINS MIDAZOLAM HYDROCHLORIDE EQUIVALENT TO MIDAZOLAM 15,0 mg | Not listed | A400760A40/2.2/0760 | Registered | S5 | None |
| Dormicum 15 mg/3 ML EACH 3 ml CONTAINS MIDAZOLAM 15 mg | 15 mg/3 ml | Q0286Q/2.2/286 | Registered | S5 | None |
| Dormicum 15 MG EACH TABLET CONTAINS MIDAZOLAM MALEATE EQUIVALENT TO 15,0 mg MIDAZOLAM | 15 mg | R0123R/2.2/123 | Registered | S5 | None |
| Dormicum 5 mg/5 ML EACH 5,0 ml AMPOULE CONTAINS MIDAZOLAM 5,0 mg | 5 mg/5 ml | T0207T/2.2/0207 | Registered | S5 | None |
| Dormicum 50 mg/10 ml* EACH 10 ml SOLUTION CONTAINS MIDAZOLAM 50 mg | 50 mg/10 ml | Y0325Y/2.2/325 | Registered | S5 | None |
Regulatory status
Where S5 sits on the scale
Prescription-only, with tighter controls on repeats.
Schedule 5 medicines need a prescription, and repeat dispensing is capped at six months in total; the prescriber must state upfront how many times, and at what intervals, it may be repeated. Extra limits apply to some uses: if it is being used for its anxiolytic, antidepressant, tranquillising or analgesic properties, it cannot be prescribed for longer than six months without a further consultation. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.
Schedule S5, matched to the Consolidated Schedules by ingredient, confidence high.
Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it.
Consolidated Schedules listings for Midazolam
S5: Midazolam
Consolidated Schedules 06 July 2026, line 9566
This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.
SAHPRA documents
Schedule Verification
Midazolam 50 mg/10 ML PHARMC, Pharmacorp (Pty) Ltd is scheduled S5 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.