Topotecan
Sold as Hycamtin, Cipla-topotecan, Topotecan-fresenius, Zolasol
(19S)-8-[(Dimethylamino)methyl]-19-ethyl-7,19-dihydroxy-17-oxa-3,13-diazapentacyclo[11.8.0.02,11.04,9.015,20]henicosa-1(21),2,4(9),5,7,10,15(20)-heptaene-14,18-dione
Drag to rotate. Structure from PubChem CID 60700.
Background
Registration
- Applicants
- 4
- Registrations
- 7
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Sandoz South Africa (Pty) LtdCertificate held by Sandoz2 of 3 cancelled | Hycamtin | 0.25mg, 0,25 mg, 1mg, 1 mg | 310300, 420739, 420740 | S4 | PIPIL |
| Cipla Medpro (Pty) LtdCancelled | Cipla-topotecan | 1 mg, 4 mg | 430006, 430007 | S4 | None |
| Fresenius Kabi South Africa (Pty) LtdCancelled | Topotecan-fresenius | 4 mg | 450532 | S4 | None |
| Ando Pharma (Pty) Ltd | Zolasol | 4 mg | 560642 | S4 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Hycamtin EACH VIAL CONTAINS TOPOTECAN HYDROCHLORIDE EQUIVALENT TO 4 mg TOPOTECAN | 0.25mg. 1mgCapsule | 31030031/26/0300Approved 9 May 2012 | Cancelled | S4 | PIPIL |
| Hycamtin 0,25 MG EACH CAPSULE CONTAINS TOPOTECAN HYDROCHLORIDE EQUIVALENT TO TOPOTECAN 0,25 mg | 0,25 mg | 42073942/26/0739 | Cancelled | S4 | None |
| Hycamtin 1 MG EACH CAPSULE CONTAINS TOPOTECAN HYDROCHLORIDE EQUIVALENT TO TOPOTECAN 1,0 mg | 1 mg | 42074042/26/0740 | Registered | S4 | None |
| Cipla-topotecan 1 MG EACH VIAL CONTAINS TOPOTECAN HYDROCHLORIDE EQUIVALENT TO TOPOTECAN 1,0 mg | 1 mg | 43000643/26/0006 | Cancelled | S4 | None |
| Cipla-topotecan 4 MG EACH VIAL CONTAINS TOPOTECAN HYDROCHLORIDE EQUIVALENT TO TOPOTECAN 4,0 mg | 4 mg | 43000743/26/0007 | Cancelled | S4 | None |
| Topotecan-fresenius 4 MG EACH VIAL CONTAINS TOPOTECAN HYDROCHLORIDE EQUIVALENT TO TOPOTECAN 4,0 mg | 4 mg | 45053245/26/0532 | Cancelled | S4 | None |
| Zolasol TOPOTECAN HYDROCHLORIDE | 4 mgPowder for concentrate for solution for infusion | 56064256/26/0642Approved 31 May 2024 | 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 Topotecan hydrochloride equivalent to topotecan
S4: Topotecan
Consolidated Schedules 06 July 2026, line 8249
Pharmacological class: Cytostatic agents (class 26)
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
Hycamtin, Sandoz South Africa (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.