Zoledronic acid
Sold as Zobone, Cipla zoledronic acid, Zolapor, Dronamyl, Zoledronic acid fresenius, Eurodron, Zoledronic acid accord, Zoldron, Zoledronic acid iv camox, Zoledronic acid iv austell, Zoledronic acid iv apex, Zoclasta, Zoltero, Bonazoll, Lonostio
(1-Hydroxy-2-imidazol-1-yl-1-phosphonoethyl)phosphonic acid
Drag to rotate. Structure from PubChem CID 68740.
Background
Registration
- Applicants
- 10
- Registrations
- 16
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Ranbaxy Pharmaceutical (Pty) LtdCertificate held by Ranbaxy Pharmaceuticals (Pty) Ltd | Zobone | 4 mg, 5 mL | 420664, 471168 | S4 | PIL |
| Cipla Medpro (Pty) LtdCancelled | Cipla zoledronic acid | Not stated | 430731 | S4 | None |
| Activo Health (Pty) Ltd | Zolapor | Not stated | 450033 | S4 | None |
| Viatris Healthcare (Pty) Ltd | Dronamyl | 4 mg/5 ml | 470039 | S4 | None |
| Fresenius Kabi South Africa (Pty) Ltd | Zoledronic acid fresenius | 4 MG/5 ML | 470262 | S4 | None |
| Biomab Innovation (Pty) Ltd | Eurodron | Not stated | 471126 | S4 | None |
| Accord Healthcare (Pty) Ltd | Zoledronic acid accord, Zoldron | 4 MG/5 ML | 480354, 480355 | S4 | None |
| Austell Pharmaceuticals (Pty) Ltd3 of 4 cancelled | Zoledronic acid iv camox, Zoledronic acid iv austell, Zoledronic acid iv apex, Zoclasta | 5 mg/100 ml | 490438, 490439, 490440, 491081 | S4 | None |
| Hetero Drugs South Africa (Pty) Ltd | Zoltero | Not stated | 510202 | S4 | None |
| Innovata pharmaceuticalsCertificate held by Lnnovata Pharmaceuticals (Pty) Ltd | Bonazoll, Lonostio | 5 mg | 550903, 560851 | S4 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Zobone EACH VIAL CONTAINS: ZOLEDRONIC ACID 4,0 mg | 4 mgPowder for solution for infusion. | 42066442/34/0664Approved 21 August 2026 | Registered | S4 | PIL |
| Cipla zoledronic acid EACH VIAL CONTAINS ZOLEDRONATE TRISODIUM EQUIVALENT TO ZOLEDRONIC ACID 4,0 mg | Not listed | 43073143/34/0731 | Cancelled | S4 | None |
| Zolapor EACH 5,0 ml SOLUTION CONTAINS ZOLEDRONATE TRISODIUM EQUIVALENT TO ZOLEDRONIC ACID 4,0 mg | Not listed | 45003345/34/0033 | Registered | S4 | None |
| Dronamyl 4 mg/5 ML EACH 5,0 mL SOLUTION CONTAINS: ZOLEDRONIC ACID 4,0 mg | 4 mg/5 ml | 47003947/32.2/0039 | Registered | S4 | None |
| Zoledronic acid 4 mg/5 ML fresenius Each 5 ml vial contains ZOLEDRONIC ACID MONOHYDRATE EQUIVALENT TO ZOLEDRONIC ACID (ANHYDROUS) 4,0 mg | 4 MG/5 ML | 47026247/34/0262 | Registered | S4 | None |
| Eurodron EACH 5,0 mL SOLUTION CONTAINS : ZOLEDRONATE TRISODIUM EQUIVALENT TO ZOLEDRONIC ACID 4,0 mg | Not listed | 47112647/32.16/1126 | Registered | S4 | None |
| Zobone solution for infusion Each 5 ml vial contains: 4,264 mg ZOLEDRONIC ACID (AS MONOHYDRATE) EQUIVALENT TO ZOLEDRONIC ACID ANHYDROUS 4,0 mg | 5 mLConcentrate for solution for infusion. | 47116847/34/1168Approved 10 August 2022 | Registered | S4 | PIL |
| Zoledronic acid 4 mg/5 ML accord Each vial contains 4,264 mg ZOLEDRONIC ACID MONOHYDRATE EQUIVALENT TO ZOLEDRONIC ACID ANHYDROUS 4,0 mg | 4 MG/5 ML | 48035448/3.5/0354 | Registered | S4 | None |
| Zoldron Each vial contains 4,264 mg ZOLEDRONIC ACID MONOHYDRATE EQUIVALENT TO ZOLEDRONIC ACID ANHYDROUS 4,0 mg | Not listed | 48035548/3.5/0355 | Registered | S4 | None |
| Zoledronic acid iv camox EACH 5,0 ml SOLUTION CONTAINS ZOLEDRONATE TRISODIUM EQUIVALENT TO ZOLEDRONIC ACID 4,0 mg | Not listed | 49043849/34/0438 | Cancelled | S4 | None |
| Zoledronic acid iv austell EACH 5,0 ml SOLUTION CONTAINS ZOLEDRONATE TRISODIUM EQUIVALENT TO ZOLEDRONIC ACID 4,0 mg | Not listed | 49043949/34/0439 | Cancelled | S4 | None |
| Zoledronic acid iv apex EACH 5,0 ml SOLUTION CONTAINS ZOLEDRONATE TRISODIUM EQUIVALENT TO ZOLEDRONIC ACID 4,0 mg | Not listed | 49044049/34/0440 | Cancelled | S4 | None |
| Zoclasta 5 mg/100 ML EACH 100,0 ml SOLUTION CONTAINS ZOLEDRONATE TRISODIUM EQUIVALENT TO ZOLEDRONIC ACID 5,0 mg | 5 mg/100 ml | 49108149/34/1081 | Registered | S4 | None |
| Zoltero Each vial with 5 ml concentrate contains 4 mg ZOLEDRONIC ACID (ANHYDROUS) EQUIVALENT TO ZOLEDRONIC ACID MONOHYDRATE 4,264 mg | Not listed | 51020251/34/0202 | Registered | S4 | None |
| Bonazoll 5 EACH 100,0 ml SOLUTION CONTAINS ZOLEDRONIC ACID MONOHYDRATE 5,0 mg | 5 mgSolution for infusion | 55090355/34/0903Approved 29 August 2023 | Registered | S4 | PIPIL |
| Lonostio EACH 5,0 ml SOLUTION CONTAINS ZOLEDRONIC ACID MONOHYDRATE EQUIVALENT TO ZOLEDRONIC ACID 4,0 mg | Not listed | 56085156/34/0851 | Registered | S4 | None |
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, 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 Zoledronic acid
S4: Zoledronic acid
Consolidated Schedules 06 July 2026, line 8422
Pharmacological class: Complementary Medicines: Health Supplements (class 34)
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.