Amorolfine
Sold as Loceryl, Onyban, Amorolfine glenmark, Amofun, Fungoryl, Amortivo, Lyrecol, Lovacil
(2S,6R)-2,6-Dimethyl-4-[2-methyl-3-[4-(2-methylbutan-2-yl)phenyl]propyl]morpholine
Drag to rotate. Structure from PubChem CID 54260.
Background
Registration
- Applicants
- 7
- Registrations
- 8
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Galderma Laboratories S.A. (Pty) LtdCertificate held by Galderma Laboratories South Africa (Pty) Ltd | Loceryl | 50 mg/1 ml | 270163 | S1 | PIPIL |
| Inova Pharmaceuticals (Pty) Ltd | Onyban | 5 % | 480207 | S1 | None |
| Glenmark Pharmaceuticals South Africa (Pty) Ltd | Amorolfine glenmark | 50 mg | 530560 | S1 | PI |
| Austell Pharmaceuticals (Pty) Ltd | Amofun, Fungoryl | 50 mg | 540172, 540173.172 | S1 | PIPIL |
| Activo Health (Pty) Ltd | Amortivo | 5 % | 550751 | S1 | None |
| Trinity Pharma (Pty) LtdCertificate held by Cipla Medpro (Pty) Ltd | Lyrecol | 5 % w/v | 560174 | S1 | PIPIL |
| Astral Pharma (Pty) Ltd | Lovacil | 5% | 561212 | S1 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Loceryl 5% EACH 1 ml NAIL LACUER CONTAINS AMOROLFINE HYDROCHLORIDE 50 mg | 50 mg/1 ml.Nail lacquer | 27016327/13.9.2/0163Approved 8 November 2021 | Registered | S1 | PIPIL |
| Onyban 5 % Each 1 ml lacquer contains AMOROLFINE 50,0 mg | 5 % | 48020748/13.8.2/0207 | Registered | S1 | None |
| Amorolfine 5% glenmark EACH 1,0 ml SOLUTION CONTAINS AMOROLFINE HYDROCHLORIDE 50,0 mg | 50 mgNail lacquer | 53056053/13.8.2/0560Approved 15 October 2024 | Registered | S1 | PI |
| Amofun 5% EACH 1,0 ml SOLUTION CONTAINS AMOROLFINE HYDROCHLORIDE EQUIVALENT TO AMOROLFINE 50,0 mg | 50 mgSolution | 54017254/13.8.2/0172Approved 14 March 2023 | Registered | S1 | PIPIL |
| Fungoryl 5 % EACH 1,0 ml SOLUTION CONTAINS AMOROLFINE HYDROCHLORIDE EQUIVALENT TO AMOROLFINE 50,0 mg | 50 mgSolution | 540173.17254/13.8.2/0173.172Approved 14 March 2023 | Registered | S1 | PIPIL |
| Amortivo 5 % EACH 1,0 ml SOLUTION CONTAINS AMOROLFINE HYDROCHLORIDE EQUIVALENT TO AMOROLFINE 50,0 mg | 5 % | 55075155/13.8.2/0751 | Registered | S1 | None |
| Lyrecol 5 % EACH 1,0 ml SOLUTION CONTAINS AMOROLFINE HYDROCHLORIDE | 5 % w/vMedicated nail lacquer | 56017456/13.9.2/0174Approved 19 September 2023 | Registered | S1 | PIPIL |
| Lovacil EACH LIQUER CONTAINS AMOROLFINE HYDROCHLORIDE EQUIVALENT TO AMOROLFINE 5,0 %w/v | 5%Nail lacquer | 56121256/13.9.2/1212Approved 18 March 2025 | Registered | S1 | PIPIL |
Regulatory status
Where S1 sits on the scale
Sold by a pharmacist, no doctor's prescription needed.
Schedule 1 medicines are normally sold by a pharmacist, or by a supervised pharmacist intern or assistant, without a doctor's visit; a veterinarian, or a licensed dispensing doctor, dentist or nurse prescriber, may also supply them. A nurse or other non-doctor prescriber may only prescribe the specific substances the Schedule names for that purpose, and may only dispense them if licensed to do so. A child under 12 may only be sold one of these medicines on a prescription, or on a written order that names the purpose and carries a signature the seller recognises.
Schedule S1, matched to the Consolidated Schedules by ingredient, confidence high.
Who may supply: A pharmacist, or a supervised pharmacist intern or assistant; manufacturers and wholesalers supplying people who may lawfully possess it; a veterinarian, who may prescribe, compound or dispense it; a medical practitioner or dentist, who may prescribe it, and may compound or dispense it only if licensed under section 22C(1)(a); a nurse or other registered non-doctor prescriber, who may prescribe only the Scheduled substances the Schedule identifies for that purpose, and dispense them if licensed to do so; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Amorolfine hydrochloride
S1: Amorolfine
Consolidated Schedules 06 July 2026, line 119
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.