Apremilast

Sold as Otezla, Aptika, Apremilast glenmark

C₂₂H₂₄N₂O₇S460.50 g/mol

N-[2-[(1S)-1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-1,3-dioxoisoindol-4-yl]acetamide

Drag to rotate. Structure from PubChem CID 11561674.

Loading Wikipedia summary

Registration

Applicants: 2
Registrations: 9
Schedule source: Consolidated Schedules 06 July 2026

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Amgen south africa (pty)ltdCancelled	Otezla	10 mg, 20 mg, 30 mg	510864, 510865, 510866	S4	None
Glenmark Pharmaceuticals South Africa (Pty) Ltd	Aptika, Apremilast glenmark	10 mg, 20 mg, 30 mg	540564, 540565, 540566, 540567.564, 540568.565, 540569.566	S4	PI PIL

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Otezla 10 MG EACH TABLET CONTAINS APREMILAST 10,0 mg	10 mg	51086451/32/0864	Cancelled	S4	None
Otezla 20 MG EACH TABLET CONTAINS APREMILAST 20,0 mg	20 mg	51086551/32/0865	Cancelled	S4	None
Otezla 30 MG EACH TABLET CONTAINS APREMILAST 30,0 mg	30 mg	51086651/32/0866	Cancelled	S4	None
Aptika 10 MG EACH TABLET CONTAINS APREMILAST 10,0 mg	10 mgTablet	54056454/13.9.1/0564Approved 14 February 2023	Registered	S4	PI PIL
Aptika 20 MG EACH TABLET CONTAINS APREMILAST 20,0 mg	20 mgTablet	54056554/13.9.1/0565Approved 14 February 2023	Registered	S4	PI PIL
Aptika 30 MG EACH TABLET CONTAINS APREMILAST 30,0 mg	30 mgTablet	54056654/13.9.1/0566Approved 14 February 2023	Registered	S4	PI PIL
Apremilast 10 MG glenmark APREMILAST	10 mgTablet	540567.56454/13.9.1/0567.564Approved 14 February 2023	Registered	S4	PI PIL
Apremilast 20 MG glenmark APREMILAST	20 mgTablet	540568.56554/13.9.1/0568.565Approved 14 February 2023	Registered	S4	PI PIL
Apremilast 30 MG glenmark APREMILAST	30 mgTablet	540569.56654/13.9.1/0569.566Approved 14 February 2023	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, 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 Apremilast

S4: Apremilast
Consolidated Schedules 06 July 2026, line 5331

Pharmacological class: Other substances or agents (class 32)

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

Professional information (PI)For healthcare professionalsAptika 10 MG, Glenmark Pharmaceuticals South Africa (Pty) Ltd Patient information leaflet (PIL)For patients and carersAptika 10 MG, Glenmark Pharmaceuticals South Africa (Pty) Ltd

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

Research articles

Loading PubMed articles

Background