Lopinavir, ritonavir

Sold as Kaletra, Aluvia, Caveerah, Raolin, Mecotril, Cotiral, Cipla-lopinavir & ritonavir os, Medpro-lopinavir & ritonavir os, Rilovia, Lopwin, Diloprit, Lopinavir and ritonavir macleods, Hetloritan, Napinor, Lopimune pellets, Lopinavir and ritonavir cipla pellets, Dupirta, Pefrilo, Grapitova, Lopinavir/ritonavir for mylan

S4Read from the PI-PIL document and verified

Combination product

This product contains more than one active ingredient, so it has no single molecular structure.

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Registration

Applicants: 14
Registrations: 27
Schedule source: SAHPRA documentation

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Abbvie (Pty) Ltd	Kaletra, Aluvia	80 mg / 20mg, 100/25, 200 mg, 50 mg	350255, 410217, 430356	S4	PI PIL
Pharmacare limited û woodmead	Caveerah	100/25, 200/50	440881, 440882	S4	None
Novagen Pharma (Pty) Ltd	Raolin	100/25 mg, 200/50 mg	450078, 450079	S4	None
Aurobindo Pharma (Pty) Ltd	Mecotril	100/25 mg, 200/50 mg	450080, 450081	S4	None
Aurogen South Africa (Pty) Ltd	Cotiral	100/25 mg, 200/50 mg	450082, 450083	S4	None
Cipla Medpro (Pty) LtdCancelled	Cipla-lopinavir & ritonavir os, Medpro-lopinavir & ritonavir os	80/20 mg/ml	450098, 450099	S4	None
Viatris Healthcare (Pty) Ltd1 of 5 cancelled	Rilovia, Dupirta, Pefrilo, Lopinavir/ritonavir for mylan	40 mg, 10 mg, 40 mg/10 mg, 200/50	450111, 450336, 550567, 550568.567, 560046	S4	PI PIL
Zentiva South Africa (Pty) Ltd	Lopwin	Not stated	470462	S4	None
Specpharm (Pty) LtdCancelled	Diloprit	Not stated	470810	S4	None
Macleods Pharmaceuticals SA (Pty) Ltd	Lopinavir and ritonavir macleods	100/25 mg, 200/50 mg	480105, 480106	S4	None
Hetero Drugs South Africa (Pty) Ltd	Hetloritan	200/50	490585	S4	None
Sandoz South Africa (Pty) Ltd	Napinor	Not stated	491075	S4	None
Cipla Medpro Manufacturing (Pty) Ltd1 of 2 cancelled	Lopimune pellets, Lopinavir and ritonavir cipla pellets	40/10	510123, 510124.123	S4	None
Juno Pharma SA (Pty) LtdCertificate held by Viatris Healthcare (Pty) Ltd	Grapitova	40 mg, 10 mg	550569.567	S4	PI PIL

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Kaletra solution EACH 1,0 ml SOLUTION CONTAINS :LOPINAVIR 80,0 mg, RITONAVIR 20,0 mg	80 mg / 20mgOral solution	35025535/20.2.8/0255Approved 25 June 2024	Registered	S4	PI PIL
Aluvia EACH TABLET CONTAINS: LOPINAVIR 200,0 mg, RITONAVIR 50,0 mg	200 mg, 50 mgFilm-coated tablets	41021741/20.2.8/0217Approved 15 April 2021	Registered	S4	PI PIL
Aluvia 100/25 EACH TABLET CONTAINS :LOPINAVIR 100,0 mg, RITONAVIR 25,0 mg	100/25Film-coated tablets	43035643/20.2.8/0356Approved 15 April 2021	Registered	S4	PI PIL
Caveerah 100/25 EACH TABLET CONTAINS LOPINAVIR 100,0 mg RITONAVIR 25,0 mg	100/25	44088144/20.2.8/0881	Registered	S4	None
Caveerah 200/50 EACH TABLET CONTAINS LOPINAVIR 200,0 mg RITONAVIR 50,0 mg	200/50	44088244/20.2.8/0882	Registered	S4	None
Raolin 100/25 MG tablets EACH TABLET CONTAINS LOPINAVIR 100,0 mg RITONAVIR 25,0 mg	100/25 mgTablets	45007845/20.2.8/0078	Registered	S4	None
Raolin 200/50 MG tablets EACH TABLET CONTAINS LOPINAVIR 200,0 mg RITONAVIR 50,0 mg	200/50 mgTablets	45007945/20.2.8/0079	Registered	S4	None
Mecotril 100/25 MG tablets EACH TABLET CONTAINS LOPINAVIR 100,0 mg RITONAVIR 25,0 mg	100/25 mgTablets	45008045/20.2.8/0080	Registered	S4	None
Mecotril 200/50 MG tablets EACH TABLET CONTAINS LOPINAVIR 200,0 mg RITONAVIR 50,0 mg	200/50 mgTablets	45008145/20.2.8/0081	Registered	S4	None
Cotiral 100/25 MG tablets EACH TABLET CONTAINS LOPINAVIR 100,0 mg RITONAVIR 25,0 mg	100/25 mgTablets	45008245/20.2.8/0082	Registered	S4	None
Cotiral 200/50 MG tablets EACH TABLET CONTAINS LOPINAVIR 200,0 mg RITONAVIR 50,0 mg	200/50 mgTablets	45008345/20.2.8/0083	Registered	S4	None
Cipla-lopinavir & ritonavir 80/20 mg/ml os EACH 1,0 ml SOLUTION CONTAINS LOPINAVIR 80,0 mg RITONAVIR 20,0 mg	80/20 mg/ml	45009845/20.2.8/0098	Cancelled	S4	None
Medpro-lopinavir & ritonavir 80/20 mg/ml os EACH 1,0 ml SOLUTION CONTAINS LOPINAVIR 80,0 mg RITONAVIR 20,0 mg	80/20 mg/ml	45009945/20.2.8/0099	Cancelled	S4	None
Rilovia 200/50 EACH TABLET CONTAINS LOPINAVIR 200,0 mg RITONAVIR 50,0 mg	200/50	45011145/20.2.8/0111	Registered	S4	None
Rilovia EACH TABLET CONTAINS LOPINAVIR 100,0 mg RITONAVIR 25,0 mg	Not listed	45033645/20.2.8/0336	Registered	S4	None
Lopwin EACH TABLET CONTAINS LOPINAVIR 200,0 mg RITONAVIR 50,0 mg	Not listed	47046247/20.2.8/0462	Registered	S4	None
Diloprit EACH TABLET CONTAINS LOPINAVIR 200,0 mg RITONAVIR 50,0 mg	Not listed	47081047/20.2.8/0810	Cancelled	S4	None
Lopinavir and ritonavir tablets macleods 100/25 MG EACH TABLET CONTAINS LOPINAVIR 100,0 mg RITONAVIR 25,0 mg	100/25 mgTablets	48010548/20.2.8/0105	Registered	S4	None
Lopinavir and ritonavir tablets macleods 200/50 MG EACH TABLET CONTAINS LOPINAVIR 200,0 mg RITONAVIR 50,0 mg	200/50 mgTablets	48010648/20.2.8/0106	Registered	S4	None
Hetloritan 200/50 EACH TABLET CONTAINS LOPINAVIR 200,0 mg RITONAVIR 50,0 mg	200/50	49058549/20.2.8/0585	Registered	S4	None
Napinor EACH TABLET CONTAINS : LOPINAVIR 200,0 mg RITONAVIR 50,0 mg	Not listed	49107549/20.2.8/1075	Registered	S4	None
Lopimune 40/10 oral pellets EACH CAPSULE CONTAINS LOPINAVIR 40,0 mg RITONAVIR 10,0 mg	40/10Oral	51012351/20.2.8/0123	Registered	S4	None
Lopinavir and ritonavir cipla 40/10 oral pellets EACH CAPSULE CONTAINS LOPINAVIR 40,0 mg RITONAVIR 10,0 mg	40/10Oral	510124.12351/20.2.8/0124.123	Cancelled	S4	None
Dupirta EACH SACHET CONTAINS LOPINAVIR 40,0 mg RITONAVIR 10,0 mg	40 mg, 10 mgOral granules	55056755/20.2.8/0567Approved 26 September 2023	Registered	S4	PI PIL
Pefrilo EACH SACHET CONTAINS LOPINAVIR 40,0 mg RITONAVIR 10,0 mg	40 mg, 10 mgOral granules	550568.56755/20.2.8/0568.567Approved 26 September 2023	Registered	S4	PI PIL
Grapitova EACH SACHET CONTAINS LOPINAVIR 40,0 mg RITONAVIR 10,0 mg	40 mg, 10 mgOral granules	550569.56755/20.2.8/0569.567Approved 26 September 2023	Registered	S4	PI PIL
Lopinavir/ritonavir 40 mg/10 MG granules for oral suspension mylan EACH SACHET CONTAINS LOPINAVIR 40,0 mg RITONAVIR 10,0 mg	40 mg/10 mgGranules oral suspension	56004656/20.2.8/0046	Cancelled	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 Lopinavir, ritonavir

S4: Lopinavir
Consolidated Schedules 06 July 2026, line 6964
S4: Ritonavir
Consolidated Schedules 06 July 2026, line 7820

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

Kaletra solution, Abbvie (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsKaletra solution, Abbvie (Pty) Ltd Patient information leaflet (PIL)For patients and carersKaletra solution, Abbvie (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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