Asacol
5-Amino-2-hydroxybenzoic acid
Drag to rotate; arrow keys step through the atoms. Structure from PubChem CID 4075.
Registration
- Applicants
- 1
- Registrations
- 5
- Schedule source
- SAHPRA documentation
Applicants and registrations
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Asacol 800 EACH TABLET CONTAINS MESALAZINE 800,0 mg | 400MG / 800MGTablet | 37062937/11.1/0629Approved 18 December 2019 | Registered | S3 | PIPIL |
| Asacol 1 600 EACH TABLET CONTAINS MESALAZINE 1 600,0 mg | 1600 mgModified-release tablet | 55066555/11.10/0665Approved 8 September 2025 | Registered | S3 | PIPIL |
| Asacol tablets EACH TABLET CONTAINS MESALAZINE 400,0 mg | Tablets | S0171S/11.10/171 | Registered | S3 | PIPIL |
| Asacol enema EACH 50,0 ml SUSPENSION CONTAINS MESALAZINE 2,0 g | 2 g,Rectal suspension. | Z0205Z/11.10/205Approved 3 July 2023 | Registered | S3 | PIPIL |
| Asacol suppositories EACH SUPPOSITORY CONTAINS MESALAZINE 500 mg | 500 mgSuppositories | Z0206Z/11.10/206Approved 22 March 2024 | Registered | S3 | PIPIL |
Regulatory status
Where S3 sits on the scale
Needs a doctor's prescription, dispensed by a pharmacist.
Schedule 3 medicines can only be sold on a prescription from an authorised prescriber, such as a doctor or dentist. A pharmacist dispenses the medicine once they have the written prescription, or a verbal instruction from a prescriber they know. 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 S3, 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 Mesalazine
S3: Mesalazine
Consolidated Schedules 06 July 2026, line 3927
Pharmacological class: Digestants. (class 11.1)
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
Schedule Verification
Asacol 800, Equity Pharmaceutical (Pty) Ltd is scheduled S3 in its official SAHPRA documents, read with 90% confidence.
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.