Ivabradine (Bradhet, Ivatero)
Ivabradine
Hetero Drugs South Africa (Pty) Ltd
Registration
- Applicant
- Hetero Drugs South Africa (Pty) Ltd
- Certificate holder
- Hetero Drugs South Africa (Pty) Ltd
- Registrations
- 4
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Bradhet 5 Each Tablet contains: Ivabradine Hydrochloride equivalent to Ivabradine 5,0 mg | 5 mg /7,5 mgFilm coated tablet | 57027757/7.1.4/0277Approved 10 June 2025 | Registered | S3 | PIPIL |
| Bradhet 7,5 Each Tablet contains: Ivabradine Hydrochloride equivalent to Ivabradine 7,5 mg | 5 mg /7,5 mgFilm coated tablet | 57027857/7.1.4/0278Approved 10 June 2025 | Registered | S3 | PIPIL |
| Ivatero 5 Each Tablet contains: Ivabradine Hydrochloride equivalent to Ivabradine 5,0 mg | 5 mg /7,5 mgFilm coated tablet | 570279.27757/7.1.4/0279.277Approved 10 June 2025 | Registered | S3 | PIPIL |
| Ivatero 7,5 Each Tablet contains: Ivabradine Hydrochloride equivalent to Ivabradine 5,0 mg | 5 mg /7,5 mgFilm coated tablet | 570280.27857/7.1.4/0280.278Approved 10 June 2025 | Registered | S3 | 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.
Consolidated Schedules listings for Ivabradine hydrochloride equivalent to ivabradine
S3: Ivabradine
Consolidated Schedules 06 July 2026, line 3830
Pharmacological class: Vasodilators - coronary and other medicines used in angina pectoris. (class 7.1.4)
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.
3-[3-[[(7S)-3,4-Dimethoxy-7-bicyclo[4.2.0]octa-1,3,5-trienyl]methyl-methylamino]propyl]-7,8-dimethoxy-2,5-dihydro-1H-3-benzazepin-4-one
Drag to rotate. Structure from PubChem CID 132999.
SAHPRA documents
Schedule Verification
This medication's schedule (S3) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.