Amoxicillin, clavulanic acid
Sold as Betaclav sf, Betaclav s, * co-amoxiclav es camox, * co-amoxiclav es apex, Ranclav, Co-amoxiclav sr sandoz, Curam sr, Heliclav sr
(2R,3Z,5R)-3-(2-Hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
Drag to rotate. Structure from PubChem CID 5280980.
Background
Registration
- Applicants
- 4
- Registrations
- 8
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Ranbaxy Pharmaceuticals (Pty) Ltd | Betaclav sf, Betaclav s | Not stated | 410911, 410912 | Not determined | None |
| Austell Pharmaceuticals (Pty) Ltd | * co-amoxiclav es camox, * co-amoxiclav es apex | 600 | 481122, 481124 | Not determined | None |
| Ranbaxy Pharmaceutical (Pty) LtdCertificate held by Ranbaxy Pharmaceuticals (Pty) Ltd | Ranclav | 1 g | 500227 | S4 | PIPIL |
| Sandoz South Africa (Pty) LtdCertificate held by Sandoz SA (Pty) Ltd | Co-amoxiclav sr sandoz, Curam sr, Heliclav sr | 1 000, 437,5 mg; 562,5 mg; 62,5 mg, 1000 | 550394, 550395.394, 550396.394 | S4 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Betaclav sf EACH 5 ML SUSPENSION CONTAINS: AMOXICILLIN TRIHYDRATE EQUIVALENT TO AMOXICILLIN 250,0 mg & POTASSIUM CLAVULANATE EQUIVALENT TO CLAVULANIC ACID 62,5 mg | Not listed | 41091141/20.1.2/0911 | Registered | Not determined | None |
| Betaclav s EACH 5 ML SUSPENSION CONTAINS AMOXICILLIN TRIHYDRATE EQUIVALENT TO AMOXICILLIN 125,0 mg and POTASSIUM CLAVULANATE EQUIVALENT TO CLAVULANIC ACID 31,25 mg | Not listed | 41091241/20.1.2/0912 | Registered | Not determined | None |
| * co-amoxiclav es 600 camox EACH 5,0 ml SUSPENSION CONTAINS: AMOXICILLIN TRIHYDRATE EQUIVALENT TO AMOXICILLIN 600,0 mg POTASSIUM CLAVULANATE EQUIVALENT TO CLAVULANIC ACID 42,9 mg | 600 | 48112248/20.1.2/1122 | Registered | Not determined | None |
| * co-amoxiclav es 600 apex EACH 5,0 ml SUSPENSION CONTAINS: AMOXICILLIN TRIHYDRATE EQUIVALENT TO AMOXICILLIN 600,0 mg POTASSIUM CLAVULANATE EQUIVALENT TO CLAVULANIC ACID 42,9 mg | 600 | 48112448/20.1.2/1124 | Registered | Not determined | None |
| Ranclav 625 EACH TABLET CONTAINS: AMOXICILLIN TRIHYDRATE EQUIVALENT TO AMOXICILLIN 500,0 mg POTASSIUM CLAVULANATE EQUIVALENT TO CLAVULANIC ACID 125,0 mg | 1 gFilm-coated tablets | 50022750/20.1.2/0227Approved 14 April 2025 | Registered | S4 | PIPIL |
| Co-amoxiclav 1 000 sr sandoz EACH TABLET CONTAINS AMOXICILLIN TRIHYDRATE EQUIVALENT TO AMOXICILLIN 562,5 mg AMOXICILLIN SODIUM EQUIVALENT TO AMOXICILLIN 437,5 mg POTASSIUM CLAVULANATE EQUIVALENT TO CLAVULANIC ACID 62,5 mg | 1 000 | 55039455/20.1.2/0394 | Registered | Not determined | None |
| Curam 1000 sr EACH TABLET CONTAINS AMOXICILLIN TRIHYDRATE EQUIVALENT TO AMOXICILLIN 562,5 mg AMOXICILLIN SODIUM EQUIVALENT TO AMOXICILLIN 437,5 mg POTASSIUM CLAVULANATE EQUIVALENT TO CLAVULANIC ACID 62,5 mg | 1000Tablets | 550395.39455/20.1.2/0395.394Approved 26 September 2023 | Registered | S4 | PIPIL |
| Heliclav 1 000 sr EACH TABLET CONTAINS AMOXICILLIN TRIHYDRATE EQUIVALENT TO AMOXICILLIN 562,5 mg AMOXICILLIN SODIUM EQUIVALENT TO AMOXICILLIN 437,5 mg POTASSIUM CLAVULANATE EQUIVALENT TO CLAVULANIC ACID 62,5 mg | 437,5 mg; 562,5 mg; 62,5 mgTablets | 550396.39455/20.1.2/0396.394Approved 26 September 2023 | Registered | S4 | PIPIL |
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 Amoxicillin trihydrate equivalent to amoxicillin, potassium clavulanate equivalent to clavulanic acid
S4: Amoxicillin
Consolidated Schedules 06 July 2026, line 5238
S4: Clavulanic acid
Consolidated Schedules 06 July 2026, line 5829
Pharmacological class: Penicillins. (class 20.1.2)
Matched through the component Amoxicillin.
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
Ranclav 625, Ranbaxy Pharmaceutical (Pty) Ltd is scheduled S4 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.