Ketorolac trometamol
Sold as Tora-dol, Acular, Toraket, Ketorolac pharma-q
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 4
- Registrations
- 8
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Ascendis Pharma (Pty) Ltd | Tora-dol | 1 %, 3 % | 280570, 280571, 280572 | Not determined | None |
| Abbvie (Pty) Ltd | Acular | 0,4 %, 5 mg/ml | 290265, A400282 | S3 | PIPIL |
| Pharmaplan (Pty) LtdCancelled | Toraket | 10 mg, 30 mg | 441047, 441048 | Not determined | None |
| Pharma-q Holdings (Pty) LtdCertificate held by Pharma-q Holdings (Pty) Ltd. | Ketorolac pharma-q | 5 mg/ mL | 470512 | S3 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Tora-dol 1 % EACH 1 ml CONTAINS KETOROLAC TROMETAMOL 10 mg | 1 % | 28057028/2.7/0570 | Registered | Not determined | None |
| Tora-dol 3 % EACH 1 ml CONTAINS KETOROLAC TROMETAMOL 30 mg | 3 % | 28057128/2.7/0571 | Registered | Not determined | None |
| Tora-dol EACH TABLET CONTAINS KETOROLAC TROMETAMOL 10 mg | Not listed | 28057228/2.7/0572 | Registered | Not determined | None |
| Acular 0,5 % EACH 1 ml SOLUTION CONTAINS :KETOROLAC TROMETAMOL 5 mg | 5 mg/mlOphthalmic solution | 29026529/15.4/0265Approved 21 April 2025 | Registered | S3 | PIPIL |
| Toraket 10 MG tablets EACH TABLET CONTAINS KETOROLAC TROMETAMOL 10,0 mg | 10 mgTablets | 44104744/2.7/1047 | Cancelled | Not determined | None |
| Toraket 30 MG injections EACH 1,0 ml SOLUTION CONTAINS KETOROLAC TROMETAMOL 30,0 mg | 30 mgInjections | 44104844/2.7/1048 | Cancelled | Not determined | None |
| Ketorolac drops pharma-q | 5 mg/ mL.Eye drops, solution. | 47051247/15.4/0512Approved 1 February 2024 | Registered | S3 | PIPIL |
| Acular 0,4 % EACH 1,0 ml SOLUTION CONTAINS :KETOROLAC TROMETHAMINE 4,0 mg | 0,4 % | A400282A40/15.4/0282 | Registered | Not determined | None |
Regulatory status
Where S3 sits on the scale
Needs a doctor's prescription, dispensed by a pharmacist.
Schedule 3 medicines can only be sold on a prescription from an authorised prescriber, such as a doctor or dentist. A pharmacist dispenses the medicine once they have the written prescription, or a verbal instruction from a prescriber they know. 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 S3, read from the product's PI-PIL leaflet.
The Consolidated Schedules list this ingredient up to S4; the leaflet's S3 applies to this product.
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 Ketorolac trometamol
S4: Ketorolac
- except when intended for ophthalmic use.
Consolidated Schedules 06 July 2026, line 6848
S4: Trometamol
Consolidated Schedules 06 July 2026, line 8299
S3: Ketorolac
- when intended for ophthalmic use.
Consolidated Schedules 06 July 2026, line 3860
Pharmacological class: Others. (class 15.4)
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
Acular 0,5 %, Abbvie (Pty) Ltd is scheduled S3 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.