Tranexamic acid
Sold as Tranic, Morwak, Cynex, Fibtin, Tranexamic acid PHARMC, Transun iv, Klotigo, Hemopron, Tranexamic pharma-q, Cykloclot, Immatra, Rubinex, Tranmenxio iv, Zamicron, Stranan, Mantexora, Cyklodus, Cyklokapron iv, Cyklokapron t
4-(Aminomethyl)cyclohexane-1-carboxylic acid
Drag to rotate. Structure from PubChem CID 5526.
Background
Registration
- Applicants
- 17
- Registrations
- 21
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Acino Pharma (Pty) Ltd | Tranic, Transun iv | Not stated | 410223, 490445 | S4 | None |
| Dr Reddyæs Laboratories (Pty) LtdCertificate held by Dr. Reddy’s Laboratories (Pty) Ltd. | Morwak | 250mgg, 500mg,750mg | 410742 | S4 | PI |
| Ranbaxy Pharmaceutical (Pty) Ltd | Cynex | 500 mg | 430263 | S4 | None |
| Pharmacare limited û woodmeadCertificate held by Pharmacare limited | Fibtin | 500 mg/5 mL | 480251 | S4 | PIPIL |
| Pharmacorp (Pty) Ltd | Tranexamic acid PHARMC | 100 mg/mL | 481085 | S4 | PIPIL |
| Pharma Dynamics (Pty) Ltd | Klotigo | 500, 1000 | 520806, 520807 | S4 | PIPIL |
| Macleods Pharmaceuticals SA (Pty) LtdCertificate held by Abex Pharmaceutica (Pty) Ltd | Hemopron | 500, 500 mg, 1 000 mg | 520808, 520809 | S4 | PIPIL |
| Pharma-q Holdings (Pty) Ltd | Tranexamic pharma-q | 1000 mg | 540223 | S4 | PIPIL |
| Juno Pharma SA (Pty) LtdCertificate held by Kahma Biotech (Pty) Ltd | Cykloclot | 100 mg | 540886 | S4 | PIPIL |
| Cipla Medpro (Pty) LtdCertificate held by Ruby Pharmaceuticals (Pty) Ltd | Immatra | 100mg | 550127 | S4 | PIPIL |
| Ruby Pharmaceuticals (Pty) Ltd | Rubinex | 100mg | 550128.127 | S4 | PIPIL |
| Biotech Laboratories (Pty) Ltd | Tranmenxio iv | 500mg | 560497 | S4 | PIPIL |
| Ascendis Pharma (Pty) Ltd | Zamicron | injection | 560639 | S4 | None |
| Austell Pharmaceuticals (Pty) Ltd | Stranan | injection | 560640.639 | S4 | None |
| RBC Pharmaceuticals (Pty) Ltd | Mantexora | Not stated | 570573 | S4 | None |
| Zydus Healthcare (Pty) Ltd | Cyklodus | Not stated | 590143 | S4 | None |
| Pfizer Laboratories (Pty) Ltd | Cyklokapron iv, Cyklokapron t | 500 | H0806, H0807 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Tranic EACH TABLET CONTAINS TRANEXAMIC ACID 500,0 mg | Not listed | 41022341/8.1/0223 | Registered | S4 | None |
| Morwak EACH TABLET CONTAINS TRANEXAMIC ACID 500,0 mg | 250mgg, 500mg,750mgTablets | 41074241/8.1/0742Approved 11 December 2019 | Registered | S4 | PI |
| Cynex 500 MG injection EACH 5,0 ml AMPOULE CONTAINS TRANEXAMIC ACID 500,0 mg | 500 mgInjection | 43026343/8.1/0263 | Registered | S4 | None |
| Fibtin injection EACH 5 mL AMPOULE CONTAINS TRANEXAMIC ACID 500,0 mg | 500 mg/5 mLSolution for injection. | 48025148/8.1/0251Approved 28 April 2021 | Registered | S4 | PIPIL |
| Tranexamic acid 100 mg/ml PHARMC EACH 5 mL AMPOULE CONTAINS TRANEXAMIC ACID 500,0 mg | 100 mg/mLSolution for injection. | 48108548/8.1/1085Approved 17 July 2024 | Registered | S4 | PIPIL |
| Transun iv Each 5 ml Ampoule contains: Tranexamic Acid | Not listed | 49044549/8.1/0445 | Registered | S4 | None |
| Klotigo 500 | 500Solution for injection/ infusion | 52080652/8.1/0806Approved 29 January 2025 | Registered | S4 | PIPIL |
| Klotigo 1000 | 1000Solution for injection/ infusion | 52080752/8.1/0807Approved 29 January 2025 | Registered | S4 | PIPIL |
| Hemopron 500 | 500Solution for injection/infusion | 52080852/8.1/0808Approved 30 May 2023 | Registered | S4 | PIPIL |
| Hemopron 1 000 | 500 mg, 1 000 mgSolution for injection/infusion | 52080952/8.1/0809Approved 30 May 2023 | Registered | S4 | PIPIL |
| Tranexamic injection pharma-q | 1000 mgInjection | 54022354/8.1/0223Approved 24 April 2022 | Registered | S4 | PIPIL |
| Cykloclot 100 mg/ml TRANEXAMIC ACID | 100 mgTablet | 54088654/8.1/0886Approved 7 February 2023 | Registered | S4 | PIPIL |
| Immatra EACH 1,0 ml SOLUTION CONTAINS TRANEXAMIC ACID 100,0 mg | 100mgSolution for injection | 55012755/8.1/0127Approved 29 March 2022 | Registered | S4 | PIPIL |
| Rubinex EACH 1,0 ml SOLUTION CONTAINS TRANEXAMIC ACID 100,0 mg | 100mgSolution for injection | 550128.12755/8.1/0128.127Approved 29 March 2022 | Registered | S4 | PIPIL |
| Tranmenxio iv EACH AMPOULE CONTAINS TRANEXAMIC ACID 500,0 mg | 500mgSolution for injection/infusion | 56049756/8.1/0497Approved 29 March 2022 | Registered | S4 | PIPIL |
| Zamicron injection EACH AMPOULE CONTAINS TRANEXAMIC ACID 500,0 mg | Injection | 56063956/8.1/0639 | Registered | S4 | None |
| Stranan injection EACH AMPOULE CONTAINS TRANEXAMIC ACID 500,0 mg | Injection | 560640.63956/8.1/0640.639 | Registered | S4 | None |
| Mantexora EACH 5,0 ml SOLUTION CONTAINS: TRANEXAMIC ACID 500,0 mg | Not listed | 57057357/8.1/0573 | Registered | S4 | None |
| Cyklodus EACH TABLET CONTAINS: TRANEXAMIC ACID 500,0 mg | Not listed | 59014359/8.1/0143 | Registered | S4 | None |
| Cyklokapron iv 500 EACH 5 ml SOLUTION CONTAINS TRANEXAMIC ACID 500 mg | 500 | H0806H/8.1/806 | Registered | S4 | None |
| Cyklokapron t 500 EACH TABLET CONTAINS TRANEXAMIC ACID 500 mg | 500 | H0807H/8.1/807 | Registered | S4 | None |
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, 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 Tranexamic acid
S4: Tranexamic acid
Consolidated Schedules 06 July 2026, line 8259
Pharmacological class: Coagulants, haemostatics. (class 8.1)
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.
SAHPRA documents
Schedule Verification
Morwak, Dr Reddyæs Laboratories (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.