Valganciclovir
Sold as Valcyte, Valganciclovir cipla, Valvir cipla, Valhet, Roivan, Quivalex, Hetvaglan, Vaglor, Ganrevi
[2-[(2-Amino-6-oxo-1H-purin-9-yl)methoxy]-3-hydroxypropyl] (2S)-2-amino-3-methylbutanoate
Drag to rotate. Structure from PubChem CID 135413535.
Background
Registration
- Applicants
- 4
- Registrations
- 11
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pharmaco Distribution (Pty) LtdCertificate held by Roche | Valcyte | 50 mg/ml, 450 | 370296, 430433 | S4 | PIPIL |
| Cipla Medpro (Pty) Ltd1 of 2 cancelled | Valganciclovir cipla, Valvir cipla | 450 | 500599, 500600 | S4 | None |
| Hetero Drugs South Africa (Pty) Ltd | Valhet, Roivan, Quivalex, Hetvaglan, Vaglor | 450, oral solution, 50 mg | 510197, 510198.197, 510199.197, 540271, 540272, 540273.271 | S4 | PIPIL |
| Austell Pharmaceuticals (Pty) Ltd | Ganrevi | Not stated | 550790 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Valcyte 450 EACH TABLET CONTAINS VALGANCICLOVIR 450,0 mg | 450Tablet. Solution | 37029637/20.2.8/0296Approved 23 November 2017 | Registered | S4 | PIPIL |
| Valcyte 50 mg/ml EACH 1,0 ml SOLUTION CONTAINS VALGANCICLOVIR 50,0 mg | 50 mg/ml | 43043343/20.2.8/0433 | Registered | S4 | None |
| Valganciclovir 450 cipla EACH TABLET CONTAINS: VALGANCICLOVIR 450,0 mg | 450 | 50059950/20.2.8/0599 | Cancelled | S4 | None |
| Valvir 450 cipla EACH TABLET CONTAINS: VALGANCICLOVIR 450 mg 4. | 450 | 50060050/20.2.8/0600 | Registered | S4 | None |
| Valhet 450 EACH TABLET CONTAINS VALGANCICLOVIR 450,0 mg | 450 | 51019751/20.2.8/0197 | Registered | S4 | None |
| Roivan 450 EACH TABLET CONTAINS VALGANCICLOVIR 450,0 mg | 450 | 510198.19751/20.2.8/0198.197 | Registered | S4 | None |
| Quivalex 450 EACH TABLET CONTAINS VALGANCICLOVIR 450,0 mg | 450 | 510199.19751/20.2.8/0199.197 | Registered | S4 | None |
| Valhet oral solution EACH 1,0 ml SOLUTION CONTAINS VALGANCICLOVIR HYDROCHLORIDE EQUIVALENT TO VALGANCICLOVIR 50,0 mg | Oral solution | 54027154/20.2.8/0271 | Registered | S4 | None |
| Hetvaglan EACH 1,0ml SOLUTION CONTAINS VALGANCICLOVIR HYDROCHLORIDE EQUIVALENT TO VALGANCICLOVIR 50,0 mg | 50 mgPowder for oral solution | 54027254/20.2.8/0272.271Approved 12 September 2023 | Registered | S4 | PIPIL |
| Vaglor EACH 1,0 ml SOLUTION CONTAINS VALGANCICLOVIR HYDROCHLORIDE EQUIVALENT TO VALGANCICLOVIR 50,0 mg | 50 mgPowder for oral solution | 540273.27154/20.2.8/073.271Approved 12 September 2023 | Registered | S4 | PIPIL |
| Ganrevi EACH TABLET CONTAINS VALGANCICLOVIR HYDROCHLORIDE EQUIVALENT TO VALGANCICLOVIR 450,0 mg | Not listed | 55079055/20.2.8/0790 | 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 Valganciclovir
S4: Valganciclovir
Consolidated Schedules 06 July 2026, line 8342
Pharmacological class: Antiviral agents. (class 20.2.8)
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.