Mycophenolate mofetil

Sold as Cellcept, Cellcept I.V., Cellcept os, Mycocept, Mymune, Immunolate, Aspencept, Mycokem, Mycophenolate alkem, Immunucept, Mycophenolate teva, Cimune, Imugraft, Micomune, Mycophenolate ascendis, Mylate, Myfenotil

S4Read from the PI-PIL document and verified

C₂₃H₃₁NO₇433.50 g/mol

2-Morpholin-4-ylethyl (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1H-2-benzofuran-5-yl)-4-methylhex-4-enoate

Drag to rotate. Structure from PubChem CID 5281078.

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Registration

Applicants: 11
Registrations: 28
Schedule source: SAHPRA documentation

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Roche Products (Pty) Ltd	Cellcept, Cellcept I.V., Cellcept os	500 mg	310134, 330201, 350057, A390230	Not determined	None
Sandoz South Africa (Pty) LtdCertificate held by Sandoz SA (Pty) Ltd12 of 4 cancelled	Mycocept, Mymune	250 mg, 500	410815, 410816, 430240, 430241	S4	PI PIL
Zydus Healthcare (Pty) Ltd	Immunolate	250, 500	420377, 430215	Not determined	None
Pharmacare limited û woodmead	Aspencept	250 mg	420988	Not determined	None
Ascend Laboratories (Pty) Ltd	Mycokem, Mycophenolate alkem	250, 500	440631, 450219, 450220, 450221	Not determined	None
Cipla Medpro (Pty) LtdCancelled	Immunucept	Not stated	451078	Not determined	None
Teva Pharmaceuticals (Pty) Ltd	Mycophenolate teva	250, 500	451086, 460322	Not determined	None
Austell Pharmaceuticals (Pty) LtdCancelled	Cimune	250, 500	460686, 460687	Not determined	None
Accord Healthcare (Pty) Ltd1 of 2 cancelled	Imugraft, Micomune	500	481152, 481156	Not determined	None
Ascendis Pharma (Pty) Ltd	Mycophenolate ascendis	250, 500 mg	560631, 561031	Not determined	None
Trinity Pharma (Pty) Ltd	Mylate, Myfenotil	250 mg, 500	590131, 590132.131, 590199, 590200.199	S4	PI PIL

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Cellcept EACH CAPSULE CONTAINS MYCOPHENOLATE MOFETIL 250,0 mg	Not listed	31013431/34/0134	Registered	Not determined	None
Cellcept I.V. EACH 1,0 ml CONTAINS MYCOPHENOLATE MOFETIL 100,0 mg	Not listed	33020133/34/0201	Registered	Not determined	None
Cellcept os EACH 1,0 ml SUSPENSION CONTAINS MYCOPHENOLATE MOFETIL 200,0 mg	Not listed	35005735/34/0057	Registered	Not determined	None
Mycocept 250 EACH CAPSULE CONTAINS MYCOPHENOLATE MOFETIL 250,0 mg	250 mgCapsules	41081541/34/0815Approved 14 May 2025	Registered	S4	PI PIL
Mymune 250 EACH CAPSULE CONTAINS MYCOPHENOLATE MOFETIL 250,0 mg	250	41081641/34/0816	Cancelled	Not determined	None
Immunolate 250 capsules EACH CAPSULE CONTAINS MYCOPHENOLATE MOFETIL 250,0 mg	250Capsules	42037742/34/0377	Registered	Not determined	None
Aspencept 250 MG EACH CAPSULE CONTAINS MYCOPHENOLATE MOFETIL 250,0 mg	250 mg	42098842/32.2/0988	Registered	Not determined	None
Immunolate 500 EACH TABLET CONTAINS MYCOPHENOLATE MOFETIL 500,0 mg	500	43021543/34/0215	Registered	Not determined	None
Mymune 500 EACH TABLET CONTAINS MYCOPHENOLATE MOFETIL 500,0 mg	500	43024043/32.2/0240	Cancelled	Not determined	None
Mycocept 500 EACH TABLET CONTAINS MYCOPHENOLATE MOFETIL 500,0 mg	250 mgCapsules	43024143/32.2/0241Approved 30 January 2025	Registered	S4	PI PIL
Mycokem 500 EACH TABLET CONTAINS MYCOPHENOLATE MOFETIL 500,0 mg	500	44063144/32.2/0631	Registered	Not determined	None
Mycophenolate alkem 250 EACH CAPSULE CONTAINS MYCOPHENOLATE MOFETIL 250,0 mg	250	45021945/34/0219	Registered	Not determined	None
Mycophenolate alkem 500 EACH TABLET CONTAINS MYCOPHENOLATE MOFETIL 500,0 mg	500	45022045/34/0220	Registered	Not determined	None
Mycokem 250 EACH CAPSULE CONTAINS MYCOPHENOLATE MOFETIL 250,0 mg	250	45022145/32.2/0221	Registered	Not determined	None
Immunucept EACH TABLET CONTAINS MYCOPHENOLATE MOFETIL 500,0 mg	Not listed	45107845/32.2/1078	Cancelled	Not determined	None
Mycophenolate teva 500 EACH TABLET CONTAINS MYCOPHENOLATE MOFETIL 500,0 mg	500	45108645/32.16/1086	Registered	Not determined	None
Mycophenolate teva 250 EACH CAPSULE CONTAINS MYCOPHENOLATE MOFETIL 250,0 mg	250	46032246/32.16/0322	Registered	Not determined	None
Cimune 250 EACH TABLET CONTAINS MYCOPHENOLATE MOFETIL 250,0 mg	250	46068646/32.2/0686	Cancelled	Not determined	None
Cimune 500 EACH TABLET CONTAINS MYCOPHENOLATE MOFETIL 500,0 mg	500	46068746/32.2/0687	Cancelled	Not determined	None
Imugraft 500 EACH TABLET CONTAINS :MYCOPHENOLATE MOFETIL 500,0 mg	500	48115248/32.2/1152	Cancelled	Not determined	None
Micomune 500 EACH TABLET CONTAINS : MYCOPHENOLATE MOFETIL 500,0 mg	500	48115648/32.2/1156	Registered	Not determined	None
Mycophenolate 500 MG ascendis EACH CAPSULE CONTAINS MYCOPHENOLATE MOFETIL 500,0 mg	500 mg	56063156/34/0631	Registered	Not determined	None
Mycophenolate 250 ascendis EACH CAPSULE CONTAINS MYCOPHENOLATE MOFETIL 250,0 mg	250	56103156/34/1031	Registered	Not determined	None
Mylate 250 EACH CAPSULE CONTAINS: MYCOPHENOLATE MOFETIL 250,0 mg	250 mgCapsule	59013159/32.16/0131Approved 23 June 2026	Registered	S4	PI PIL
Myfenotil 250 EACH CAPSULE CONTAINS: MYCOPHENOLATE MOFETIL 250,0 mg	250 mgCapsule	590132.13159/32.16/0132.131Approved 23 June 2026	Registered	S4	PI PIL
Mylate 500 EACH TABLET CONTAINS: MYCOPHENOLATE MOFETIL 500,0 mg	500	59019959/32.16/0199	Registered	Not determined	None
Myfenotil 500 EACH TABLET CONTAINS: MYCOPHENOLATE MOFETIL 500,0 mg	500	590200.19959/32.16/0200.199	Registered	Not determined	None
Cellcept 500 MG EACH TABLET CONTAINS MYCOPHENOLATE MOFETIL 500,0 mg	500 mg	A390230A39/34/0230	Registered	Not determined	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.

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

Mycocept 250, Sandoz South Africa (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsMycocept 250, Sandoz South Africa (Pty) Ltd Patient information leaflet (PIL)For patients and carersMycocept 250, Sandoz South Africa (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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