Datrenal
3-(7-Amino-3-oxo-1H-isoindol-2-yl)piperidine-2,6-dione
Drag to rotate; arrow keys step through the atoms. Structure from PubChem CID 216326.
Registration
- Applicants
- 1
- Registrations
- 7
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Aurogen South Africa (Pty) Ltd | Datrenal | 2,5 mg, 5 mg, 7,5 mg, 10 mg, 15 mg, 20 mg, 25 mg | 560511, 560512, 560513, 560514, 560515, 560516, 560517 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Datrenal 2,5 MG EACH CAPSULE CONTAINS LENALIDOMIDE 2,5 mg | 2,5 mg | 56051156/32/0511 | Registrered | S4 | None |
| Datrenal 5 MG EACH CAPSULE CONTAINS LENALIDOMIDE 5,0 mg | 5 mg | 56051256/32/0512 | Registrered | S4 | None |
| Datrenal 7,5 MG EACH CAPSULE CONTAINS LENALIDOMIDE 7,5 mg | 7,5 mg | 56051356/32/0513 | Registrered | S4 | None |
| Datrenal 10 MG EACH CAPSULE CONTAINS LENALIDOMIDE 10,0 mg | 10 mg | 56051456/32/0514 | Registrered | S4 | None |
| Datrenal 15 MG EACH CAPSULE CONTAINS LENALIDOMIDE 15,0 mg | 15 mg | 56051556/32/0515 | Registrered | S4 | None |
| Datrenal 20 MG EACH CAPSULE CONTAINS LENALIDOMIDE 20,0 mg | 20 mg | 56051656/32/0516 | Registrered | S4 | None |
| Datrenal 25 MG EACH CAPSULE CONTAINS LENALIDOMIDE 25,0 mg | 25 mg | 56051756/32/0517 | Registrered | 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 Lenalidomide
S4: Lenalidomide
Consolidated Schedules 06 July 2026, line 6886
Pharmacological class: Other substances or agents (class 32)
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.
Background
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.