Risedronate
Sold as Actamax, Dronex, Osteonel once-a-week, Risacto, Sandoz risedronate, Etanordes, Odron, Bontelvia
(1-Hydroxy-1-phosphono-2-pyridin-3-ylethyl)phosphonic acid
Drag to rotate. Structure from PubChem CID 5245.
Background
Registration
- Applicants
- 7
- Registrations
- 8
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pharma Dynamics (Pty) Ltd | Actamax | 35 mg | 420455 | S3 | PIL |
| Ascendis Pharma (Pty) Ltd | Dronex | 35 | 430343 | S3 | None |
| Acino Pharma (Pty) Ltd | Osteonel once-a-week | Not stated | 430636 | S3 | None |
| Biotech Laboratories (Pty) Ltd | Risacto | 35 | 431158 | S3 | None |
| Oethmaan Biosims (Pty) Ltd | Sandoz risedronate | 35 | 431159 | S3 | None |
| Aurogen South Africa (Pty) Ltd | Etanordes, Odron | 35 mg | 450868, 450869 | S3 | PIPIL |
| Macleods Pharmaceuticals SA (Pty) Ltd | Bontelvia | 35 mg | 460904 | S3 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Actamax 35 MG EACH TABLET CONTAINS RISEDRONATE SODIUM 35,0 mg | 35 mgFilm coated tablet. | 42045542/3.2/0455Approved 16 May 2022 | Registered | S3 | PIL |
| Dronex 35 EACH TABLET CONTAINS RISEDRONATE SODIUM 35,0 mg | 35 | 43034343/3.2/0343 | Registered | S3 | None |
| Osteonel once-a-week EACH TABLET CONTAINS RISEDRONATE SODIUM 35,0 mg | Not listed | 43063643/3.2/0636 | Registered | S3 | None |
| Risacto 35 EACH TABLET CONTAINS RISEDRONATE SODIUM 35,0 mg | 35 | 43115843/3.2/1158 | Registered | S3 | None |
| Sandoz risedronate 35 EACH TABLET CONTAINS RISEDRONATE SODIUM 35,0 mg | 35 | 43115943/3.2/1159 | Registered | S3 | None |
| Etanordes 35 MG tablets EACH TABLET CONTAINS RISEDRONATE 35,0 mg | 35 mgTablets | 45086845/3.2/0868 | Registered | S3 | None |
| Odron 35 MG tablets EACH TABLET CONTAINS RISEDRONATE 35,0 mg | 35 mgTablets | 45086945/3.2/0869Approved 26 February 2021 | Registered | S3 | PIPIL |
| Bontelvia 35 MG EACH TABLET CONTAINS:RISEDRONATE 35,0 mg | 35 mg | 46090446/3.2/0904 | Registered | S3 | 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, 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 Risedronate sodium
S3: Risedronate
Consolidated Schedules 06 July 2026, line 4223
Pharmacological class: Non-hormonal preparations. (class 3.2)
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
Odron 35 MG tablets, Aurogen South Africa (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.