Midazolam (Midazolam Hexal Biotech, Mizam ( ))
Midazolam
Biotech Laboratories (Pty) Ltd
Registration
- Applicant
- Biotech Laboratories (Pty) Ltd
- Registrations
- 5
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| 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 |
| 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 |
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.
8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine
Drag to rotate. Structure from PubChem CID 4192.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.