Mesalazine (Pentasa)
Mesalazine
Ferring (Pty) Ltd
Registration
- Applicant
- Ferring (Pty) Ltd
- Certificate holder
- Ferring (Pty) Ltd.
- Registrations
- 5
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pentasa 500 MG EACH TABLET CONTAINS MESALAZINE 500,0 mg | 500 mgTablets | 33008833/11/0088Approved 19 March 2026 | Registered | S3 | PIL |
| Pentasa sachets 2 g EACH SACHET CONTAINS MESALAZINE 2,0 g | 2 gSachets | 43001443/11/0014 | Registered | S3 | None |
| Pentasa 1 g enema EACH ENEMA CONTAINS MESALAZINE 1,0 g | 1 gSuspension | 44088844/11/0888Approved 9 January 2015 | Registered | S3 | PIPIL |
| Pentasa sachet 4 g EACH SACHET CONTAINS MESALAZINE 4,0 g | 4 gSachet | 56113556/11/1135 | Registered | S3 | None |
| Pentasa 1 g EACH SUPPOSITORY CONTAINS MESALAZINE 1,0 g | 1 g | A400374A40/11/0374 | Registered | S3 | None |
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, 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; 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: Medicines acting on gastro-intestinal tract (class 11)
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
This medication's schedule (S3) 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.