Metronidazole (Bio-metronidazole Iv, Bio Metronidazole, Bio-metronidazole)
Metronidazole
Biotech Laboratories (Pty) Ltd
Registration
- Applicant
- Biotech Laboratories (Pty) Ltd
- Certificate holder
- Biotech Laboratories (Pty) Ltd.
- Registrations
- 3
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Bio-metronidazole iv EACH 100,0 ml SOLUTION CONTAINS METRONIDAZOLE 500,0 mg | 100 mlSolution for infusion. | 42056742/20.2/0567Approved 20 October 2025 | Registered | S4 | PIPIL |
| Bio metronidazole 200 EACH TABLET CONTAINS METRONIDAZOLE 200 mg | 200 | V0370V/20.2.6/370 | Registered | Not determined | None |
| Bio-metronidazole 400 EACH TABLET CONTAINS METRONIDAZOLE 400 mg | 400 | V0371V/20.2.6/371 | Registered | Not determined | None |
Regulatory status
Where S4 sits on the scale
Prescription-only medicine.
Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. 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 S4, read from the product's PI-PIL leaflet.
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; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Metronidazole
S4: Metronidazole
- intended and registered for use in pigeons in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947) and
- intended for human vaginal use, specifically for the treatment of recurrent bacterial vaginosis. (S2)
Consolidated Schedules 06 July 2026, lines 7108 to 7117
S2: Metronidazole
- when intended for human vaginal use, specifically for the treatment of recurrent bacterial vaginosis and except when intended and registered for use in pigeons in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947). (S4)
Consolidated Schedules 06 July 2026, lines 2343 to 2345
Pharmacological class: Other than antibiotics. (class 20.2)
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.
2-(2-Methyl-5-nitroimidazol-1-yl)ethanol
Drag to rotate. Structure from PubChem CID 4173.
SAHPRA documents
Schedule Verification
This medication's schedule (S4) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.