Vardenafil
Sold as Levitra, Levitra odt, Vivanza, Vivanza odt, Varfydo odt, Makdefil odt, Varfydo fc, Makdefil fc
2-[2-Ethoxy-5-(4-ethylpiperazin-1-yl)sulfonylphenyl]-5-methyl-7-propyl-3H-imidazo[5,1-f][1,2,4]triazin-4-one
Drag to rotate. Structure from PubChem CID 135400189.
Background
Registration
- Applicants
- 2
- Registrations
- 15
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Bayer (Pty) Ltd û Isando6 of 7 cancelled | Levitra, Levitra odt, Vivanza, Vivanza odt | 5 mg, 10, 20 mg | 360515, 360516, 360517, 441049, 490685, 490687, 490688 | S4 | None |
| Macleods Pharmaceuticals SA (Pty) Ltd | Varfydo odt, Makdefil odt, Varfydo fc, Makdefil fc | 5 MG, 10 MG, 20 MG | 510538, 510539.538, 519011, 519012, 519013, 519014.011, 519015.012, 519016.013 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Levitra 5 EACH TABLET CONTAINS VARDENAFIL 5,0 mg | 5 | 36051536/7.1.5/0515 | Cancelled | S4 | None |
| Levitra 10 EACH TABLET CONTAINS VARDENAFIL 10,0 mg | 10 | 36051636/7.1.5/0516 | Cancelled | S4 | None |
| Levitra 20 EACH TABLET CONTAINS :VARDENAFIL 20,0 mg | 20 | 36051736/7.1.5/0517 | Cancelled | S4 | None |
| Levitra odt 10 EACH TABLET CONTAINS VARDENAFIL 10,0 mg | 10 | 44104944/7.1.5/1049 | Cancelled | S4 | None |
| Vivanza 5 MG Each Tablet contains: Vardenafil 5 mg | 5 mg | 49068549/7.1.5/0685 | Cancelled | S4 | None |
| Vivanza 20 MG Each Tablet contains: Vardenafil 20 mg | 20 mg | 49068749/7.1.5/0687 | Cancelled | S4 | None |
| Vivanza odt 10 Each tablet contains: Vardenafil Hydrochloride equivalent to Vardenafil 10,0 mg | 10 | 49068849/7.1.5/0688 | Registered | S4 | None |
| Varfydo 10 MG odt Each tablet contains VARDENAFIL HYDROCHLORIDE EQUIVALENT TO VARDENAFIL 10,0 mg | 10 MG | 51053851/7.1.5/0538 | Registered | S4 | None |
| Makdefil 10 MG odt Each tablet contains VARDENAFIL HYDROCHLORIDE EQUIVALENT TO VARDENAFIL 10,0 mg | 10 MG | 510539.53851/7.1.5/0539.538 | Registered | S4 | None |
| Varfydo 5 MG fc Each tablet contains VARDENAFIL HYDROCHLORIDE EQUIVALENT TO VARDENAFIL 5,0 mg | 5 MG | 51901151/7.1.5/9011 | Registered | S4 | None |
| Varfydo 10 MG fc Each tablet contains VARDENAFIL HYDROCHLORIDE EQUIVALENT TO VARDENAFIL 10,0 mg | 10 MG | 51901251/7.1.5/9012 | Registered | S4 | None |
| Varfydo 20 MG fc Each tablet contains VARDENAFIL HYDROCHLORIDE EQUIVALENT TO VARDENAFIL 20,0 mg | 20 MG | 51901351/7.1.5/9013 | Registered | S4 | None |
| Makdefil 5 MG fc Each tablet contains VARDENAFIL HYDROCHLORIDE EQUIVALENT TO VARDENAFIL 5,0 mg | 5 MG | 519014.01151/7.1.5/9014.011 | Registered | S4 | None |
| Makdefil 10 MG fc Each tablet contains VARDENAFIL HYDROCHLORIDE EQUIVALENT TO VARDENAFIL 10,0 mg | 10 MG | 519015.01251/7.1.5/9015.012 | Registered | S4 | None |
| Makdefil 20 MG fc Each tablet contains VARDENAFIL HYDROCHLORIDE EQUIVALENT TO VARDENAFIL 20,0 mg | 20 MG | 519016.01351/7.1.5/9016.013 | 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 Vardenafil
S4: Vardenafil
Consolidated Schedules 06 July 2026, line 8348
Pharmacological class: Vasodilators - peripheral. (class 7.1.5)
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
SAHPRA has not published a professional information or patient information leaflet for this product.