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zameds

Mesalazine

Sold as Pentasa, Asacol, Salofalk, Mezavant, Coltra, Zylamene sr, Colizem, Mesasal

S3
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C7H7NO3153.14 g/mol

5-Amino-2-hydroxybenzoic acid

Drag to rotate. Structure from PubChem CID 4075.

Background

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Registration

Applicants
7
Registrations
23
Schedule source
Consolidated Schedules 06 July 2026

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Ferring (Pty) LtdCertificate held by Ferring (Pty) Ltd.Pentasa1 g, 2 g, 4 g, 500 mg330088, 430014, 440888, 561135, A400374S3PIPIL
Equity Pharmaceutical (Pty) LtdCertificate held by Equity pharmaceuticals, Equity Pharmaceuticals (Pty) Ltd, Equity Pharmaceuticals (Pty) Ltd.Asacol, Coltra2 g,, 400MG / 800MG, 400, 500 mg, 800, 1600 mg, tablets370629, 460739, 460740, 460808, 550665, S0171, Z0205, Z0206S3PIPIL
Cipla Medpro (Pty) Ltd1 of 4 cancelledSalofalk1 g, 1,5 g, 500 mg, 1000 mg430086, 430195, 430196, 430700S3None
Takeda (Pty) LtdMezavant1200 mg450463S3PIPIL
Zydus Healthcare (Pty) LtdZylamene sr1 200, 800560648, 560649S3None
Ranbaxy Pharmaceutical (Pty) LtdColizemNot stated570064S3None
Pharmacare limited û woodmeadCancelledMesasal250 mg, 500 mgY0006, Y0007S3None

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Pentasa 500 MG

EACH TABLET CONTAINS MESALAZINE 500,0 mg

500 mgTablets33008833/11/0088Approved 19 March 2026RegisteredS3PIL
Asacol 800

EACH TABLET CONTAINS MESALAZINE 800,0 mg

400MG / 800MGTablet37062937/11.1/0629Approved 18 December 2019RegisteredS3PIPIL
Pentasa sachets 2 g

EACH SACHET CONTAINS MESALAZINE 2,0 g

2 gSachets43001443/11/0014RegisteredS3None
Salofalk 1,5 g

Each Sachet Contains: Mesalazine 1,5 mg

1,5 g43008643/11.10/0086RegisteredS3None
Salofalk 500 MG

EACH SACHET CONTAINS MESALAZINE 500,0 mg

500 mg43019543/11.10/0195CancelledS3None
Salofalk 1000 MG

EACH SACHET CONTAINS MESALAZINE 1000,0 mg

1000 mg43019643/11.10/0196RegisteredS3None
Salofalk 1 g suppository

EACH SUPPOSITORY CONTAINS MESALAZINE 1,0 g

1 gSuppository43070043/11.10/0700RegisteredS3None
Pentasa 1 g enema

EACH ENEMA CONTAINS MESALAZINE 1,0 g

1 gSuspension44088844/11/0888Approved 9 January 2015RegisteredS3PIPIL
Mezavant

EACH TABLET CONTAINS MESALAZINE 1 200,0 mg

1200 mgFilm-coated tablet45046345/11/0463Approved 16 May 2025RegisteredS3PIPIL
Coltra 400

EACH TABLET CONTAINS MESALAZINE 400,0 mg

40046073946/11.10/0739RegisteredS3None
Coltra 800

EACH TABLET CONTAINS MESALAZINE 800,0 mg

80046074046/11.10/0740RegisteredS3None
Coltra 500

EACH SUPPOSITORY CONTAINS MESALAZINE 500,0 mg

500 mgSuppositories46080846/11.10/0808Approved 22 March 2024RegisteredS3PIPIL
Asacol 1 600

EACH TABLET CONTAINS MESALAZINE 1 600,0 mg

1600 mgModified-release tablet55066555/11.10/0665Approved 8 September 2025RegisteredS3PIPIL
Zylamene sr 800

EACH TABLET CONTAINS MESALAZINE 800,0 mg

80056064856/11.10/0648RegisteredS3None
Zylamene sr 1 200

EACH LOZENGE CONTAINS MESALAZINE 1 200,0 mg

1 20056064956/11.10/0649RegisteredS3None
Pentasa sachet 4 g

EACH SACHET CONTAINS MESALAZINE 4,0 g

4 gSachet56113556/11/1135RegisteredS3None
Colizem

EACH TABLET CONTAINS MESALAZINE 1,2 g

Not listed57006457/11.4.3/0064RegisteredS3None
Pentasa 1 g

EACH SUPPOSITORY CONTAINS MESALAZINE 1,0 g

1 gA400374A40/11/0374RegisteredS3None
Asacol tablets

EACH TABLET CONTAINS MESALAZINE 400,0 mg

TabletsS0171S/11.10/171RegisteredS3None
Mesasal tablets 250 MG

EACH TABLET CONTAINS MESALAZINE 250 mg

250 mgTabletsY0006Y/11.9.2/6CancelledS3None
Mesasal tablets 500 MG

EACH TABLET CONTAINS MESALAZINE 500 mg

500 mgTabletsY0007Y/11.9.2/7CancelledS3None
Asacol enema

EACH 50,0 ml SUSPENSION CONTAINS MESALAZINE 2,0 g

2 g,Rectal suspension.Z0205Z/11.10/205Approved 3 July 2023RegisteredS3PIPIL
Asacol suppositories

EACH SUPPOSITORY CONTAINS MESALAZINE 500 mg

500 mgSuppositoriesZ0206Z/11.10/206Approved 22 March 2024RegisteredS3PIPIL

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 verified from official documents

Schedule Verification

Asacol 800, Equity Pharmaceutical (Pty) Ltd is scheduled S3 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsAsacol 800, Equity Pharmaceutical (Pty) LtdPatient information leaflet (PIL)For patients and carersPentasa 500 MG, Ferring (Pty) Ltd

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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