8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine
Drag to rotate; arrow keys step through the atoms. Structure from PubChem CID 4192.
Registration
- Applicants
- 1
- Registrations
- 5
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Dormicum 7,5 MG EACH TABLET CONTAINS MIDAZOLAM 7,5 mg | 7,5 mg | 27007827/2.2/0078 | Registered | S5 | PIPIL |
| Dormicum 15 mg/3 ML EACH 3 ml CONTAINS MIDAZOLAM 15 mg | 15 mg/3 ml | Q0286Q/2.2/286 | Registered | S5 | PIPIL |
| Dormicum 15 MG EACH TABLET CONTAINS MIDAZOLAM MALEATE EQUIVALENT TO 15,0 mg MIDAZOLAM | 15 mg | R0123R/2.2/123 | Registered | S5 | PIPIL |
| 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 | PIPIL |
| Dormicum 50 mg/10 ml* EACH 10 ml SOLUTION CONTAINS MIDAZOLAM 50 mg | 50 mg/10 ml | Y0325Y/2.2/325 | Registered | S5 | PIPIL |
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
Pharmacological class: Sedatives, hypnotics. (class 2.2)
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.
Background
SAHPRA documents
These documents come from SAHPRA's PI-PIL repository unless the line under a document says otherwise. Always consult with a healthcare professional for medical advice.