Dolutegravir

Sold as Tivicay, Gravita, Olegra, Aurogra, Dolutegravir cipla, Dalimune, Lutavir, Hetvir, Ravic, *Myltega, Dolutegravir mylan, Aspen dolutegravir, Gradovir, Vidoteg, Tedotig, Myltega, Ristegra, Syromak odt, Kovasyp odt, Teravilad, Maktegir, Syromak, Teralavid

S4Read from the PI-PIL document and verified

C₂₀H₁₉F₂N₃O₅419.40 g/mol

(3S,7R)-N-[(2,4-Difluorophenyl)methyl]-11-hydroxy-7-methyl-9,12-dioxo-4-oxa-1,8-diazatricyclo[8.4.0.03,8]tetradeca-10,13-diene-13-carboxamide

Drag to rotate. Structure from PubChem CID 54726191.

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Registration

Applicants: 10
Registrations: 23
Schedule source: SAHPRA documentation

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Glaxosmithkline South Africa (Pty) LimitedCancelled	Tivicay	25 mg	510371	Not determined	None
Aurogen South Africa (Pty) LtdCertificate held by Aurobindo Pharma (Pty) Ltd	Gravita, Aurogra	50 mg	510913, 510915.913	S4	PI PIL
Aurobindo Pharma (Pty) Ltd	Olegra	50 mg	510914.913	S4	PI PIL
Cipla Medpro Manufacturing (Pty) LtdCertificate held by Cipla Medpro (Pty) Ltd.	Dolutegravir cipla, Dalimune	50 mg	511031, 511032.1031	S4	PI PIL
Hetero Drugs South Africa (Pty) Ltd	Lutavir, Hetvir, Ravic	50	520001, 520002.001, 520003.001	Not determined	None
Viatris Healthcare (Pty) LtdCertificate held by Mylan (Pty) Ltd	*Myltega, Dolutegravir mylan, Myltega, Ristegra	10 mg, 50 mg	520004, 520005.004, 560018, 560019.018	S4	PI PIL
Pharmacare limited û woodmeadCertificate held by Pharmacare limited	Aspen dolutegravir, Gradovir	50 mg	521004, 521005.004	S4	PI PIL
Ranbaxy (SA) (Pty) Ltd	Vidoteg, Tedotig	Not stated	530181, 530182.181	Not determined	None
Macleods Pharmaceuticals SA (Pty) Ltd	Syromak odt, Kovasyp odt, Maktegir, Syromak	10, 50 mg	560719, 560720.719, 561110, 561111.1110	Not determined	None
Laurus Generics SA (Pty) LtdCertificate held by Umsebe Healthcare (Pty) Ltd	Teravilad, Teralavid	50 mg	560876, 580005	S4	PI PIL

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Tivicay 25 MG Each Tablet Contains: Dolutegravir sodium Equivalent to Dolutegravir 25 mg	25 mg	51037151/20.2.8/0371	Cancelled	Not determined	None
Gravita EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg	Not listed	51091351/20.2.8/0913	Registered	Not determined	None
Olegra EACH TABLET CONTAINS: DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg	50 mgFilm-coated tablet	510914.91351/20.2.8/0914.913Approved 11 August 2023	Registered	S4	PI PIL
Aurogra EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg	50 mgFilm-coated tablet	510915.91351/20.2.8/0915.913Approved 1 January 2022	Registered	S4	PI PIL
Dolutegravir cipla 50 EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM 50,0 mg	50 mgFilm-coated tablets	51103151/20.2.8/1031Approved 18 November 2021	Registered	S4	PI PIL
Dalimune EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM 50,0 mg	50 mgFilm-coated tablets	511032.103151/20.2.8/1032.1031Approved 20 February 2024	Registered	S4	PI PIL
Lutavir 50 EACH TABLET CONTAINS: DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg	50	52000152/20.2.8/0001	Registered	Not determined	None
Hetvir 50 EACH TABLET CONTAINS: DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg	50	520002.00152/20.2.8/0002.001	Registered	Not determined	None
Ravic 50 EACH TABLET CONTAINS: DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg	50	520003.00152/20.2.8/0003.001	Registered	Not determined	None
*Myltega 50 MG tablets EACH TABLET CONTAINS: DOLUTEGRAVIR 50,0 mg	50 mgTablets	52000452/20.2.8/0004	Registered	Not determined	None
Dolutegravir mylan EACH TABLET CONATINS: DOLUTEGRAVIR 50,0 mg	50 mgFilm-coated tablet	520005.00452/20.2.8/0005.004Approved 5 April 2022	Registered	S4	PI PIL
Aspen dolutegravir EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50, 0 mg	50 mgFilm-coated tablets	52100452/20.2.8/1004Approved 17 January 2022	Registered	S4	PI PIL
Gradovir EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50, 0 mg	50 mgFilm-coated tablets	521005.00452/20.2.8/1005.004Approved 17 January 2022	Registered	S4	PI PIL
Vidoteg EACH TABLET CONTAINS DOLUTEGRAVIR 50,0 mg	Not listed	53018153/20.2.8/0181	Registered	Not determined	None
Tedotig EACH TABLET CONTAINS DOLUTEGRAVIR 50,0 mg	Not listed	530182.18153/20.2.8/0182.181	Registered	Not determined	None
Myltega 10 MG dispersible tablets EACH DISPERSIBLE TABLET CONTAINS DOLUTEGRAVIR 10,0 mg	10 mgDispersible tablets	56001856/20.2.8/0018	Registered	Not determined	None
Ristegra dispersible tablets EACH DISPERSIBLE TABLET CONTAINS DOLUTEGRAVIR 10,0 mg	10 mgDispersible tablet	560019.01856/20.2.8/0019.018Approved 21 June 2022	Registered	S4	PI PIL
Syromak 10 odt EACH DISPERSIBLE TABLET CONTAINS : Dolutegravir Sodium equivalent to Dolutegravir 10,0 mg	10	56071956/20.2.8/0719	Registered	Not determined	None
Kovasyp 10 odt EACH DISPERSIBLE TABLET CONTAINS: DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 10,0 mg	10	560720.71956/20.2.8/0720.719	Registered	Not determined	None
Teravilad EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg	Not listed	56087656/20.2.8/0876	Registered	Not determined	None
Maktegir 50 MG EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg	50 mg	56111056/20.2.8/1110	Registered	Not determined	None
Syromak 50 MG EACH TABLET CONTAINS DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg	50 mg	561111.111056/20.2.8/1111.1110	Registered	Not determined	None
Teralavid EACH TABLET CONTAIN:S DOLUTEGRAVIR SODIUM EQUIVALENT TO DOLUTEGRAVIR 50,0 mg	50 mgFim-coated tablets	58000558/20.2.8/0005Approved 25 September 2024	Registered	S4	PI PIL

Regulatory status

Where S4 sits on the scale

S0S1S2S3S4S5S6S7S8

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.

Consolidated Schedules listings for Dolutegravir sodium equivalent to dolutegravir

S4: Dolutegravir
Consolidated Schedules 06 July 2026, line 6100
S4: Lamivudine
Consolidated Schedules 06 July 2026, line 6850

Pharmacological class: Antiviral agents. (class 20.2.8)

Matched through the component Lamivudine.

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

Schedule verified from official documents

Schedule Verification

Olegra, Aurobindo Pharma (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsOlegra, Aurobindo Pharma (Pty) Ltd Patient information leaflet (PIL)For patients and carersOlegra, Aurobindo Pharma (Pty) Ltd

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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