Amoxicillin (Orasil, Co-amoxiclav Unimed)
Amoxicillin
Unimed Healthcare (Pty) Ltd
Registration
- Applicant
- Unimed Healthcare (Pty) Ltd
- Certificate holder
- Unimed Healthcare (Pty) Ltd
- Registrations
- 5
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Orasil 250 | 250Capsules | 50053550/20.1.2/0535Approved 30 May 2025 | Registered | S4 | PIPIL |
| Orasil 500 | 500Capsules | 50053650/20.1.2/0536Approved 30 May 2025 | Registered | S4 | PIPIL |
| Co-amoxiclav 375 unimed | 375Film-coated tablets | 50097550/20.1.2/0975Approved 22 November 2024 | Registered | S4 | PIPIL |
| Co-amoxiclav 625 unimed | 625Film-coated tablets | 50097650/20.1.2/0976Approved 22 November 2024 | Registered | S4 | PIPIL |
| Co-amoxiclav 1000 unimed | 1000Film-coated tablets | 50097750/20.1.2/0977Approved 22 November 2024 | 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
S4: Amoxicillin
Consolidated Schedules 06 July 2026, line 5238
Pharmacological class: Penicillins. (class 20.1.2)
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.
(2S,5R,6R)-6-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
Drag to rotate. Structure from PubChem CID 33613.
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.