Darunavir

Sold as Prezista, Paranvir, Darunavir cipla cipla, Nuradar, Norugenir, Vunad, Dunarid

S4Read from the PI-PIL document and verified

C₂₇H₃₇N₃O₇S547.70 g/mol

[(3AS,4R,6aR)-2,3,3a,4,5,6a-hexahydrofuro[2,3-b]furan-4-yl] N-[(2S,3R)-4-[(4-aminophenyl)sulfonyl-(2-methylpropyl)amino]-3-hydroxy-1-phenylbutan-2-yl]carbamate

Drag to rotate. Structure from PubChem CID 213039.

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Registration

Applicants: 5
Registrations: 21
Schedule source: SAHPRA documentation

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Janssen Pharmaceutica (Pty) LtdCertificate held by Aspen pharmacare	Prezista	400 mg, 600 mg	450616, 471173	S4	PI PIL
Cipla Medpro Manufacturing (Pty) Ltd6 of 7 cancelled	Paranvir, Darunavir cipla cipla	75, 150, 400, 600	500609, 500610, 500612, 500613, 500614, 500615, 500616	S4	None
Aurobindo Pharma (Pty) Ltd	Nuradar	600 mg	530239, 530240, 530241	S4	PI PIL
Aurogen South Africa (Pty) Ltd	Norugenir	400 mg, 600 mg, 800 mg	530242.239, 530243.24, 530244.241	S4	None
Hetero Drugs South Africa (Pty) Ltd	Vunad, Dunarid	400, 600, 800	560883, 560884, 560885, 560886.883, 560887.884, 560888.885	S4	None

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Prezista 600 MG EACH TABLET CONTAINS DARUNAVIR ETHANOLATE EQUIVALENT TO DARUNAVIR 600,0 mg	600 mgTablet	45061645/20.2.8/0616Approved 20 June 2013	Registered	S4	PI PIL
Prezista 400 MG EACH TABLET CONTAINS DARUNAVIR ETHANOLATE EQUIVALENT TO DARUNAVIR 400,0 mg	400 mgTablet	47117347/20.2.8/1173Approved 20 June 2013	Registered	S4	PI PIL
Paranvir 75 Each Tablet contains: Darunavir Ethanolate equivalent to Darunavir 75,0 mg	75	50060950/20.2.8/0609	Cancelled	S4	None
Paranvir 150 Each Tablet contains: Darunavir Ethanolate equivalent to Darunavir 150,0 mg	150	50061050/20.2.8/0610	Cancelled	S4	None
Paranvir 600 Each Tablet contains: Darunavir Ethanolate equivalent to Darunavir600.0 mg	600	50061250/20.2.8/0612	Registered	S4	None
Darunavir cipla 75 cipla Each Tablet contains: Darunavir Ethanolate equivalent to Darunavir 75,0 mg	75	50061350/20.2.8/0613	Cancelled	S4	None
Darunavir cipla 150 cipla Each Tablet contains: Darunavir Ethanolate equivalent to Darunavir 150,0 mg	150	50061450/20.2.8/0614	Cancelled	S4	None
Darunavir cipla 400 cipla Each Tablet contains: Darunavir Ethanolate equivalent to Darunavir 400,0 mg	400	50061550/20.2.8/0615	Cancelled	S4	None
Darunavir cipla 600 cipla Each Tablet contains: Darunavir Ethanolate equivalent to Darunavir 600,0 mg	600	50061650/20.2.8/0616	Cancelled	S4	None
Nuradar 400 EACH TABLET CONTAINS DARUNAVIR PROPYLENE GLYCOLATE EQUIVALENT TO DARUNAVIR 400,0 mg	600 mgTablets	53023953/20.2.8/0239Approved 18 August 2020	Registered	S4	PI PIL
Nuradar 600 EACH TABLET CONTAINS DARUNAVIR PROPYLENE GLYCOLATE EQUIVALENT TO DARUNAVIR 600,0 mg	600 mgTablets	53024053/20.2.8/0240Approved 18 August 2020	Registered	S4	PI PIL
Nuradar 800 EACH TABLET CONTAINS DARUNAVIR PROPYLENE GLYCOLATE EQUIVALENT TO DARUNAVIR 800,0 mg	600 mgTablets	53024153/20.2.8/0241Approved 18 August 2020	Registered	S4	PI PIL
Norugenir 400 MG EACH TABLET CONTAINS DARUNAVIR PROPYLENE GLYCOLATE EQUIVALENT TO DARUNAVIR 400,0 mg	400 mg	530242.23953/20.2.8/0242.239	Registered	S4	None
Norugenir 600 MG EACH TABLET CONTAINS DARUNAVIR PROPYLENE GLYCOLATE EQUIVALENT TO DARUNAVIR 600,0 mg	600 mg	530243.2453/20.2.8/0243.240	Registered	S4	None
Norugenir 800 MG EACH TABLET CONTAINS DARUNAVIR PROPYLENE GLYCOLATE EQUIVALENT TO DARUNAVIR 800,0 mg	800 mg	530244.24153/20.2.8/0244.241	Registered	S4	None
Vunad 400 EACH TABLET CONTAINS DARUNAVIR 400,0 mg	400	56088356/20.2.8/0883	Registered	S4	None
Vunad 600 EACH TABLET CONTAINS DARUNAVIR 600,0 mg	600	56088456/20.2.8/0884	Registered	S4	None
Vunad 800 EACH TABLET CONTAINS DARUNAVIR 800,0 mg	800	56088556/20.2.8/0885	Registered	S4	None
Dunarid 400 EACH TABLET CONTAINS DARUNAVIR 400,0 mg	400	560886.88356/20.2.8/0886.883	Registered	S4	None
Dunarid 600 EACH TABLET CONTAINS DARUNAVIR 600,0 mg	600	560887.88456/20.2.8/0887.884	Registered	S4	None
Dunarid 800 EACH TABLET CONTAINS DARUNAVIR 800,0 mg	800	560888.88556/20.2.8/0888.885	Registered	S4	None

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 Darunavir ethanolate equivalent to darunavir

S4: Darunavir
Consolidated Schedules 06 July 2026, line 5956

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

Schedule verified from official documents

Schedule Verification

Prezista 600 MG, Janssen Pharmaceutica (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsPrezista 600 MG, Janssen Pharmaceutica (Pty) Ltd Patient information leaflet (PIL)For patients and carersPrezista 600 MG, Janssen Pharmaceutica (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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