Zoledronate trisodium
Sold as Zometa, Zomedron, Zosteopor, Zomabon, Aclasta
No structure available
This product's active ingredient could not be matched to a single known compound.
Background
Registration
- Applicants
- 5
- Registrations
- 5
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Novartis South Africa (Pty) LtdCancelled | Zometa | 4 mg | 380086 | Not determined | PIPIL |
| Cipla Medpro (Pty) Ltd | Zomedron | Not stated | 430613 | Not determined | None |
| Adcock Ingram Critical Care (Pty) Ltd | Zosteopor | Not stated | 450165 | Not determined | None |
| Actor Pharma (Pty) Ltd - ApplicantCancelled | Zomabon | Not stated | 450435 | Not determined | None |
| Sandoz South Africa (Pty) LtdCertificate held by Sandoz SA (Pty) Ltd | Aclasta | solution for infusion | A390575 | S4 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Zometa 4mg EACH VIAL CONTAINS: ZOLEDRONATE TRISODIUM 4,0 mg | 4 mgConcentrate for solution for infusion | 38008638/34/0086Approved 16 August 2021 | Cancelled | Not determined | PIPIL |
| Zomedron EACH VIAL CONTAINS ZOLEDRONATE TRISODIUM 4,0 mg | Not listed | 43061343/34/0613 | Registered | Not determined | None |
| Zosteopor EACH 5,0 ml SOLUTION CONTAINS ZOLEDRONATE TRISODIUM 4,0 mg | Not listed | 45016545/34/0165 | Registered | Not determined | None |
| Zomabon EACH 5,0 ml SOLUTION CONTAINS ZOLEDRONATE TRISODIUM 4,0 mg | Not listed | 45043545/34/0435 | Cancelled | Not determined | None |
| Aclasta EACH 100,0 ml SOLUTION CONTAINS ZOLEDRONATE TRISODIUM 5,0 mg | 5 mg/100 m_Solution for infusion | A390575A39/34/0575Approved 2 March 2012 | 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.
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.