Acetylcysteine (Gencetyl, Ukastyn, Rocylteine)
Acetylcysteine
Aurogen South Africa (Pty) Ltd
Registration
- Applicant
- Aurogen South Africa (Pty) Ltd
- Registrations
- 6
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Gencetyl 200 MG EACH TABLET CONTAINS ACETYLCYSTEINE 200,0 mg | 200 mg | 56013956/10.3/0139 | Registered | Not determined | None |
| Gencetyl 600 MG EACH TABLET CONTAINS ACETYLCYSTEINE 600,0 mg | 600 mg | 56014056/10.3/0140 | Registered | Not determined | None |
| Ukastyn 200 MG EACH TABLET CONTAINS ACETYLCYSTEINE 200,0 mg | 200 mg | 560141.13956/10.3/0141.139 | Cancelled | Not determined | None |
| Ukastyn 600 MG EACH TABLET CONTAINS ACETYLCYSTEINE 600,0 mg | 600 mg | 560142.14056/10.3/0142.140 | Cancelled | Not determined | None |
| Rocylteine 200 MG EACH TABLET CONTAINS ACETYLCYSTEINE 200,0 mg | 200 mg | 560143.13956/10.3/0143.139 | Registered | Not determined | None |
| Rocylteine 600 MG EACH TABLET CONTAINS ACETYLCYSTEINE 600,0 mg | 600 mg | 560144.14056/10.3/0144.140 | 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
S3: Acetylcysteine
- when intended for injection or for the management of paracetamol overdosage;
- except when used as a mucolytic in acute respiratory conditions for a maximum treatment period of 14 days. (S1)
Consolidated Schedules 06 July 2026, lines 3109 to 3114
S1: Acetylcysteine
- when used as a mucolytic in acute respiratory conditions for a maximum treatment period of 14 days;
- except when intended for injection or for the management of paracetamol overdosage. (S3)
Consolidated Schedules 06 July 2026, lines 102 to 106
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.
(2R)-2-Acetamido-3-sulfanylpropanoic acid
Drag to rotate. Structure from PubChem CID 12035.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.