Etifoxine
Sold as Stresigen, Neusera, Kalmexan, Etifoxine biotech, Calmatrin, Enervex, Anxette, Anxilo, Stresam
6-Chloro-N-ethyl-4-methyl-4-phenyl-1H-3,1-benzoxazin-2-imine
Drag to rotate. Structure from PubChem CID 135413553.
Background
Registration
- Applicants
- 6
- Registrations
- 9
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pharma Dynamics (Pty) Ltd | Stresigen | 50 mg | 590102 | S5 | None |
| Activo Health (Pty) Ltd | Neusera | Not stated | 590103 | S5 | None |
| Biotech Laboratories (Pty) Ltd | Kalmexan, Etifoxine biotech | 50 mg | 590167, 590168.167 | S5 | PIPIL |
| Trinity Pharma (Pty) Ltd | Calmatrin, Enervex | 50 | 590183, 590184.183 | S5 | None |
| Abex Pharmaceutica (Pty) Ltd | Anxette, Anxilo | Not stated | 590224, 590225.224 | S5 | None |
| Adcock ingram limitedCertificate held by Adcock ingram | Stresam | 50 mg | A390072 | S5 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Stresigen 50 MG EACH CAPSULE CONTAINS: ETIFOXINE HYDROCHLORIDE 50,0 mg | 50 mg | 59010259/2.6/0102 | Registered | S5 | None |
| Neusera EACH CAPSULE CONTAINS: ETIFOXINE HYDROCHLORIDE 50,0 mg | Not listed | 59010359/2.6/0103 | Registered | S5 | None |
| Kalmexan EACH CAPSULE CONTAINS: ETIFOXINE HYDROCHLORIDE 50,0 mg | 50 mgHard capsule | 59016759/2.6/0167Approved 14 July 2026 | Registered | S5 | PIPIL |
| Etifoxine 50 biotech EACH CAPSULE CONTAINS: ETIFOXINE HYDROCHLORIDE 50,0 mg | 50 mgHard capsule | 590168.16759/2.6/0168.167Approved 14 July 2026 | Registered | S5 | PIPIL |
| Calmatrin 50 EACH CAPSULE CONTAINS: ETIFOXINE HYDROCHLORIDE 50,0 mg | 50 | 59018359/2.6/0183 | Registered | S5 | None |
| Enervex 50 EACH CAPSULE CONTAINS: ETIFOXINE HYDROCHLORIDE 50,0 mg | 50 | 590184.18359/2.6/0184.183 | Registered | S5 | None |
| Anxette EACH CAPSULE CONTAINS: ETIFOXINE HYDROCHLORIDE 50,0 mg | Not listed | 59022459/2.6/0224 | Registered | S5 | None |
| Anxilo EACH CAPSULE CONTAINS: ETIFOXINE HYDROCHLORIDE 50,0 mg | Not listed | 590225.22459/2.6/0225.224 | Registered | S5 | None |
| Stresam EACH CAPSULE CONTAINS ETIFOXINE HYDROCHLORIDE 50,0 mg | 50 mgCapsule | A390072A39/2.6/0072Approved 2 August 2022 | Registered | S5 | PIPIL |
Regulatory status
Where S5 sits on the scale
Prescription-only, with tighter controls on repeats.
Schedule 5 medicines need a prescription, and repeat dispensing is capped at six months in total; the prescriber must state upfront how many times, and at what intervals, it may be repeated. Extra limits apply to some uses: if it is being used for its anxiolytic, antidepressant, tranquillising or analgesic properties, it cannot be prescribed for longer than six months without a further consultation. 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 S5, 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.
Consolidated Schedules listings for Etifoxine hydrochloride
S5: Etifoxine
Consolidated Schedules 06 July 2026, line 9427
Pharmacological class: Tranquillisers. (class 2.6)
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
Kalmexan, Biotech Laboratories (Pty) Ltd is scheduled S5 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.