Melatonin
Sold as Circadin, Cadiatev, Melocirc, Vigisom, Remolat, Melatonin AURO
N-[2-(5-Methoxy-1H-indol-3-yl)ethyl]acetamide
Drag to rotate. Structure from PubChem CID 896.
Background
Registration
- Applicants
- 4
- Registrations
- 6
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Acino Pharma (Pty) Ltd | Circadin, Vigisom | 2 mg | 440001, 590054 | Not determined | None |
| Teva Pharmaceuticals (Pty) Ltd | Cadiatev | 2 mg | 560389 | Not determined | PIPIL |
| Pharma Dynamics (Pty) Ltd | Melocirc | Not stated | 580115 | Not determined | None |
| Aurogen South Africa (Pty) Ltd | Remolat, Melatonin AURO | Not stated | 590578, 590579.578 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Circadin 2 MG EACH TABLET CONTAINS MELATONIN 2,0 mg | 2 mg | 44000144/2.2/0001 | Registered | Not determined | None |
| Cadiatev EACH TABLET CONTAINS MELATONIN 2,0 mg | 2 mgProlonged-release tablets. | 56038956/2.2/0389Approved 30 October 2024 | Registered | Not determined | PIPIL |
| Melocirc EACH TABLET CONTAINS: MELATONIN 2,0 mg | Not listed | 58011558/2.2/0115 | Registered | Not determined | None |
| Vigisom EACH TABLET CONTAINS MELATONIN 2,0 mg | Not listed | 59005459/2.2/0054 | Registered | Not determined | None |
| Remolat EACH TABLET CONTAINS: MELATONIN 2,0 mg | Not listed | 59057859/2.2/0578 | Registered | Not determined | None |
| Melatonin AURO EACH TABLET CONTAINS: MELATONIN 2,0 mg | Not listed | 590579.57859/2.2/0579.578 | Registered | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
Listings for this ingredient that could not be applied to this product
S4: Melatonin
- except when used for the treatment of desyncronosis (jet-lag) in doses not exceeding 6 milligrams daily. (S2).
Consolidated Schedules 06 July 2026, lines 7043 to 7044
S2: Melatonin
- when used for the treatment of desyncronosis (jet-lag) in doses not exceeding 6 milligrams daily.
Consolidated Schedules 06 July 2026, line 2282
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.