Leuprolide
Sold as Prinolid, Genprolex, Preulad, Lucrin depot pds
No structure available
This product's active ingredient could not be matched to a single known compound.
Background
Registration
- Applicants
- 3
- Registrations
- 7
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Eurolab (Pty) Ltd | Prinolid | 3,75 mg, 7,5 mg, 11,25 mg | 53/21.10/0734, 530733, 530735 | S4 | PIPIL |
| Aurogen South Africa (Pty) LtdCertificate held by Aurogen SA (Pty) Ltd | Genprolex, Preulad | 5 mg, 9 mg | 540089, 540090.089 | S4 | PIPIL |
| Abbvie (Pty) Ltd | Lucrin depot pds | 3,75 mg, 11,25 mg | 590185, 590186 | S4 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Prinolid 7,5 LEUPROLIDE ACETATE | 7,5 mgInjection | 53/21.10/0734Approved 24 January 2023 | Registered | S4 | PIPIL |
| Prinolid 3,75 LEUPROLIDE ACETATE | 3,75 mgInjection | 53073353/21.10/0733Approved 24 January 2023 | Registered | S4 | PIPIL |
| Prinolid 11,25 EACH VIAL CONTAINS LEUPROLIDE ACETATE 11,25 mg | 11,25 mgInjection | 53073553/21.10/0735Approved 24 January 2023 | Registered | S4 | PIPIL |
| Genprolex EACH 1,0 ml SOLUTION CONTAINS LEUPROLIDE ACETATE 5,0 mg | 5 mg, 9 mgInjection | 54008954/21.10/0089Approved 24 October 2023 | Registered | S4 | PIPIL |
| Preulad EACH 1,0 ml SOLUTION CONTAINS LEUPROLIDE ACETATE 5,0 mg | 5 mg, 9 mgInjection | 540090.08954/21.10/0090.089Approved 24 October 2023 | Registered | S4 | PIPIL |
| Lucrin depot 3,75 MG pds EACH DOSE CONTAINS: LEUPROLIDE ACETATE 3,75 mg | 3,75 mgLyophilised microspheres and sterile diluent suspension for injection | 59018559/21.10/0185Approved 20 October 2025 | Registered | S4 | PIPIL |
| Lucrin depot 11,25 MG pds EACH DOSE CONTAINS: LEUPROLIDE ACETATE 11,25 mg | 11,25 mgLyophilised microspheres and sterile diluent for suspension for injection | 59018659/21.10/0186Approved 20 October 2025 | Registered | S4 | PIPIL |
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, read from the product's PI-PIL leaflet.
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 Leuprolide acetate
S4: Leuprolide acetate
Consolidated Schedules 06 July 2026, line 6900
Pharmacological class: Trophic hormones. (class 21.10)
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
Prinolid 7,5, Eurolab (Pty) Ltd is scheduled S4 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.