Modafinil

Sold as Provigil, Modalert, Modafinil ipharma, Prolert, Modiva

S5Read from the PI-PIL document and verified

C₁₅H₁₅NO₂S273.40 g/mol

2-Benzhydrylsulfinylacetamide

Drag to rotate. Structure from PubChem CID 4236.

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Registration

Applicants: 4
Registrations: 8
Schedule source: SAHPRA documentation

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Acino Pharma (Pty) LtdCertificate held by Litha Pharma (Pty) Ltd	Provigil	100mg	370025	S5	PI
Ranbaxy (SA) (Pty) LtdCancelled	Modalert	100, 200	430261, 430262	S5	None
Ipharma (Pty) Ltd	Modafinil ipharma	100 mg	490260	S5	PI PIL
Abex Pharmaceutica (Pty) Ltd	Prolert, Modiva	100, 200	520812, 520813, 520814.812, 520815.813	S5	None

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Provigil 100 EACH TABLET CONTAINS MODAFINIL 100,00 mg	100mgTablet	37002537/1.1/0025Approved 5 October 2007	Registered	S5	PI
Modalert 100 EACH TABLET CONTAINS MODAFINIL 100,0 mg	100	43026143/1.1/0261	Cancelled	S5	None
Modalert 200 EACH TABLET CONTAINS MODAFINIL 200,0 mg	200	43026243/1.1/0262	Cancelled	S5	None
Modafinil 100 ipharma	100 mgTablets	49026049/1.1/0260Approved 30 November 2021	Registered	S5	PI PIL
Prolert 100 EACH TABLET CONTAINS: MODAFINIL 100,0 mg	100	52081252/1.1/0812	Registered	S5	None
Prolert 200 EACH TABLET CONTAINS: MODAFINIL 200,0 mg	200	52081352/1.1/0813	Registered	S5	None
Modiva 100 EACH TABLET CONTAINS: MODAFINIL 100,0 mg	100	520814.81252/1.1/0814.812	Registered	S5	None
Modiva 200 EACH TABLET CONTAINS: MODAFINIL 200,0 mg	200	520815.81352/1.1/0815.813	Registered	S5	None

Regulatory status

Where S5 sits on the scale

S0S1S2S3S4S5S6S7S8

Prescription-only, with tighter controls on repeats.

Schedule 5 medicines need a prescription, and repeat dispensing is capped at six months in total; the prescriber must state upfront how many times, and at what intervals, it may be repeated. Extra limits apply to some uses: if it is being used for its anxiolytic, antidepressant, tranquillising or analgesic properties, it cannot be prescribed for longer than six months without a further consultation. 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 S5, 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.

Consolidated Schedules listings for Modafinil

S5: Modafinil
Consolidated Schedules 06 July 2026, line 9574

Pharmacological class: Central analeptics. (class 1.1)

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

Provigil 100, Acino Pharma (Pty) Ltd is scheduled S5 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsProvigil 100, Acino Pharma (Pty) Ltd Patient information leaflet (PIL)For patients and carersModafinil 100 ipharma, Ipharma (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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