Dexketoprofen (Ketesse, Keral)
Dexketoprofen
Menarini South Africa (Pty) Ltd
Registration
- Applicant
- Menarini South Africa (Pty) Ltd
- Certificate holder
- Lebasi Pharmaceuticals (Pty) Ltd
- Registrations
- 4
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Ketesse 50 mg/2 ML EACH 2,0 ml SOLUTION CONTAINS: DEXKETOPROFEN TROMETAMOL EQUIVALENT TO DEXKETOPROFEN 50,0 mg | 50 mg/2 mlSolution for injection/infusion | 54053454/2.7/0534Approved 3 July 2023 | Registered | Not determined | None |
| Keral 50 mg/2 ML EACH 2,0 ml SOLUTION CONTAINS: DEXKETOPROFEN TROMETAMOL EQUIVALENT TO DEXKETOPROFEN 50,0 mg | 50 mg/2 mlSolution for injection/infusion | 540535.53454/2.7/0535.534Approved 3 July 2023 | Registered | Not determined | PIPIL |
| Ketesse 25 MG EACH TABLET CONTAINS DEXKETOPROFEN 25,0 mg | 25 mgTablets | 54053654/2.7/0536Approved 3 July 2023 | Registered | S3 | PIPIL |
| Keral 25 MG EACH TABLET CONTAINS DEXKETOPROFEN 25,0 mg | 25 mgTablets | 540537.53654/2.7/0537.536Approved 6 July 2023 | Registered | Not determined | PIPIL |
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.
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.
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.
(2S)-2-(3-Benzoylphenyl)propanoic acid
Drag to rotate. Structure from PubChem CID 667550.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.