Is Mycophenolic acid registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 15 valid registrations of Mycophenolic acid, including ACCEPT 250MG CAPSULE (250 mg, Capsule, hard, SAR 225.65); ACCEPT 500MG F.C.TAB (500 mg, Film-coated tablet, SAR 194.55); CELLCEPT 250 MG CAPS (250 mg, Capsule, SAR 313.95); CELLCEPT 500 mg tablet (500 mg, Film-coated tablet, SAR 251.15); CELLONA 500 mg F.C.TAB (500 mg, Film-coated tablet, SAR 583.65).

Is Mycophenolic acid approved by the US FDA?

Drugs@FDA lists 68 application product lines for Mycophenolic acid, including CELLCEPT (Prescription); CELLCEPT (Prescription); CELLCEPT (Prescription); CELLCEPT (Prescription); MYFORTIC (Prescription).

Is Mycophenolic acid authorised in the European Union?

EMA lists 4 centrally authorised medicines containing Mycophenolic acid: CellCept, Mycophenolate mofetil Teva, Myfenax, Myclausen.

Are there safety signals or safety updates for Mycophenolic acid?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2025-06-30).

Active substance

Mycophenolic acid

SFDA 20
US FDA 68
EMA 4
Health Canada 24
US price lines 10
NHS prices 5
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ACCEPT 250MG CAPSULE	250 mg	Capsule, hard · Oral use	100 Blister	SAR 225.65	Generic · Prescription	Accord Healthcare Limited	Valid
ACCEPT 500MG F.C.TAB	500 mg	Film-coated tablet · Oral use	50 Blister	SAR 194.55	Generic · Prescription	Accord Healthcare Limited	Valid
CELLCEPT 250 MG CAPS	250 mg	Capsule · Oral use	100 Bottle	SAR 313.95	NCE · Prescription	ROCHE	Valid
CELLCEPT 500 mg tablet	500 mg	Film-coated tablet · Oral use	50 Bottle	SAR 251.15	NCE · Prescription	ROCHE	Valid
CELLONA 500 mg F.C.TAB	500 mg	Film-coated tablet · Oral use	150 Blister	SAR 583.65	Generic · Prescription	SPIMACO ADDWAEIH	Valid
LAMUCON 500 mg F.C.TAB	500 mg	Film-coated tablet · Oral use	50 Blister	SAR 158.50	Generic · Prescription	HEXAL AG	Valid
MOFETAB 500 MG FILM COATED TABLET	500 mg	Film-coated tablet · Oral use	150 Blister	SAR 715.75	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
MYFORTIC 360 MG E.C.TABLET	360 mg	Gastro-resistant tablet · Oral use	120 Blister	SAR 828.10	NCE · Prescription	NOVARTIS	Valid
MYORA 500 MG FILM COATED TABLET	500 mg	Film-coated tablet · Oral use	50 Blister	SAR 194.55	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Mofecon-DR	180 mg	Prolonged-release tablet · Oral use	60 Blister	SAR 306.40	Generic · Prescription	Enmaeyat Pharmaceutical Industries Co	Valid
Mofecon-DR	360 mg	Prolonged-release tablet · Oral use	60 Blister	SAR 536.20	Generic · Prescription	Enmaeyat Pharmaceutical Industries Co	Valid
Mycophenolate Mofetil Marcan	200 mg/ml	Powder for oral suspension · Oral use	1 Bottle	SAR 886.05	Generic · Prescription	Marcan Pharmaceuticals Inc	Valid
Mycophenolate Sodium Emcure	360 mg	Gastro-resistant tablet · Oral use	60 Blister	SAR 351.95	Generic · Prescription	Emcure Pharmaceuticals Ltd.	Valid
Resepta	360 mg	Gastro-resistant tablet · Oral use	120 Blister	SAR 786.70	Generic · Prescription	Accord Healthcare Limited	Valid
Resepta	180 mg	Gastro-resistant tablet · Oral use	120 Blister	SAR 393.35	Generic · Prescription	Accord Healthcare Limited	Valid
CELLCEPT 500MG TAB	500 mg	Tablet · Oral use	150 Bottle	SAR 1851.65	NCE · Prescription	ROCHE	Withdrawn by MAH · Not Marketed
MELNOLATE 250 mg Capsule	250 mg	Capsule · Oral use	100 Blister	SAR 240.15	Generic · Prescription	APOTEX INC. (SIGNET SITE)	Withdrawn by MAH · Not Marketed
MELNOLATE 500 mg Tablet	500 mg	Tablet · Oral use	50 Blister	SAR 240.15	Generic · Prescription	APOTEX INC. (SIGNET SITE)	Withdrawn by MAH · Not Marketed
MYFORTIC 180MG E.C.TABLET	180 mg	Gastro-resistant tablet · Oral use	120 Blister	SAR 677.30	NCE · Prescription	NOVARTIS PHARMA AG	Withdrawn by MAH · Not Marketed
MYFORTIC 180MG E.C.TABLET	180 mg	Gastro-resistant tablet · Oral use	120 Blister	SAR 677.30	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

AUTOIMMUNE HEPATITIS; CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY; ECZEMA; GLOMERULAR DISEASE; GRAFT VERSUS HOST DISEASE; GRANULOMATOSIS WITH POLYANGIITIS AND MICROSCOPIC POLYANGIITIS; IMMUNE THROMBOCYPTOPENIC PUPURA; LICHEN PLANUS; MYASTHENIA GRAVIS; MYOSITIS; NON-INFECTIOUS UVEITIS; PEMPHIGOID; PEMPHIGUS; POLYCYTHEMIA VERA - PRURITUS; RENAL TRANSPLANT; SARCOIDOSIS; SECONDARY UVEITIS, NON-INFECTIOUS; SJOGREN'S SYNDROME; SYSTEMIC LUPUS ERYTHEMATOSUS; THROMBOTIC THROMBOCYTOPENIC PURPURA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
CELLCEPT	250MG	capsule · oral	ROCHE PALO	Prescription	3 May 1995
CELLCEPT	500MG	tablet · oral	ROCHE PALO	Prescription	19 Jun 1997
CELLCEPT	500MG/VIAL	injectable · injection	ROCHE PALO	Prescription	12 Aug 1998
CELLCEPT	200MG/ML	for suspension · oral	ROCHE PALO	Prescription	1 Oct 1998
MYFORTIC	EQ 180MG BASE; EQ 360MG BASE	tablet, delayed release · oral	NOVARTIS	Prescription	27 Feb 2004
MYCOPHENOLATE MOFETIL	250MG	capsule · oral	SANDOZ	Prescription	15 Oct 2008
MYCOPHENOLATE MOFETIL	500MG	tablet · oral	SANDOZ	Prescription	15 Oct 2008
MYCOPHENOLATE MOFETIL	500MG	tablet · oral	ACCORD HLTHCARE	Prescription	4 May 2009
MYCOPHENOLATE MOFETIL	250MG	capsule · oral	ACCORD HLTHCARE	Prescription	4 May 2009
MYCOPHENOLATE MOFETIL	250MG	capsule · oral	TEVA PHARMS	Prescription	6 May 2009
MYCOPHENOLATE MOFETIL	250MG	capsule · oral	STRIDES PHARMA	Prescription	10 Jun 2010
MYCOPHENOLATE MOFETIL	500MG	tablet · oral	STRIDES PHARMA	Prescription	10 Jun 2010
MYCOPHENOLATE MOFETIL	500MG	tablet · oral	ALKEM LABS LTD	Prescription	4 Nov 2011
MYCOPHENOLATE SODIUM	EQ 180MG BASE; EQ 360MG BASE	tablet, delayed release · oral	APOTEX INC	Prescription	21 Aug 2012
MYCOPHENOLATE MOFETIL	250MG	capsule · oral	ALKEM LABS LTD	Prescription	13 Jun 2013
MYCOPHENOLATE MOFETIL	200MG/ML	for suspension · oral	ALKEM LABS LTD	Prescription	14 Nov 2014
MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	injectable · injection	PH HEALTH	Prescription	28 Oct 2016
MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	injectable · injection	RISING	Prescription	28 Feb 2017
MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	injectable · injection	MYLAN LABS LTD	Prescription	31 Mar 2017
MYCOPHENOLATE SODIUM	EQ 180MG BASE; EQ 360MG BASE	tablet, delayed release · oral	ACCORD HLTHCARE	Prescription	23 Aug 2017
MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	injectable · injection	ZYDUS PHARMS	Prescription	31 Aug 2017
MYCOPHENOLATE MOFETIL	250MG	capsule · oral	ZHEJIANG HISUN PHARM	Prescription	13 Nov 2017
MYCOPHENOLATE MOFETIL	500MG	tablet · oral	ZHEJIANG HISUN PHARM	Prescription	16 Nov 2017
MYCOPHENOLATE MOFETIL	250MG	capsule · oral	CONCORD BIOTECH LTD	Prescription	8 Jan 2019
MYCOPHENOLATE MOFETIL	200MG/ML	for suspension · oral	VISTAPHARM LLC	Prescription	12 Feb 2019

43 more — full table

EMA European Union — centrally authorised medicines

CellCept Roche Registration GmbH · Authorised · authorised 14 Feb 1996 · ATC L04AA06

Therapeutic indication (EMA)

CellCept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult and paediatric (1 to 18 years of age) patients receiving allogeneic renal, cardiac or hepatic transplants.

Mycophenolate mofetil Teva Teva Pharma B.V. · Authorised · authorised 21 Feb 2008 · ATC L04AA06

Therapeutic indication (EMA)

Mycophenolate mofetil Teva is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.

Myfenax Teva B.V. · Authorised · authorised 21 Feb 2008 · ATC L04AA06

Therapeutic indication (EMA)

Myfenax is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.

Myclausen Passauer Pharma GmbH · Authorised · authorised 7 Oct 2010 · ATC L04AA06

Therapeutic indication (EMA)

Myclausen is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACH-MYCOPHENOLATE	02378574	500 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
ACH-MYCOPHENOLATE	02383780	250 MG	CAPSULE · ORAL	ACCORD HEALTHCARE INC
APO-MYCOPHENOLIC ACID	02372738	180 MG	TABLET (ENTERIC-COATED) · ORAL	APOTEX INC
APO-MYCOPHENOLIC ACID	02372746	360 MG	TABLET (ENTERIC-COATED) · ORAL	APOTEX INC
CELLCEPT	02192748	250 MG	CAPSULE · ORAL	HOFFMANN-LA ROCHE LIMITED
CELLCEPT	02237484	500 MG	TABLET · ORAL	HOFFMANN-LA ROCHE LIMITED
CELLCEPT	02242145	200 MG / ML	POWDER FOR SUSPENSION · ORAL	HOFFMANN-LA ROCHE LIMITED
CELLCEPT I.V.	02240347	500 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	HOFFMANN-LA ROCHE LIMITED
JAMP MYCOPHENOLIC ACID	02518511	360 MG	TABLET (ENTERIC-COATED) · ORAL	JAMP PHARMA CORPORATION
JAMP MYCOPHENOLIC ACID	02518538	180 MG	TABLET (ENTERIC-COATED) · ORAL	JAMP PHARMA CORPORATION
JAMP-MYCOPHENOLATE	02380382	500 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP-MYCOPHENOLATE CAPSULES	02386399	250 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
MAR-MYCOPHENOLATE MOFETIL	02522233	200 MG / ML	POWDER FOR SUSPENSION · ORAL	MARCAN PHARMACEUTICALS INC
MAR-MYCOPHENOLIC ACID	02511673	180 MG	TABLET (ENTERIC-COATED) · ORAL	MARCAN PHARMACEUTICALS INC
MAR-MYCOPHENOLIC ACID	02511681	360 MG	TABLET (ENTERIC-COATED) · ORAL	MARCAN PHARMACEUTICALS INC
MYCOPHENOLATE MOFETIL	02457369	250 MG	CAPSULE · ORAL	SANIS HEALTH INC
MYCOPHENOLATE MOFETIL	02457377	500 MG	TABLET · ORAL	SANIS HEALTH INC
MYCOPHENOLATE MOFETIL FOR INJECTION, USP	02444836	500 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	ACCORD HEALTHCARE INC
MYFORTIC	02264560	180 MG	TABLET (DELAYED-RELEASE) · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
MYFORTIC	02264579	360 MG	TABLET (DELAYED-RELEASE) · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
SANDOZ MYCOPHENOLATE MOFETIL	02313855	500 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ MYCOPHENOLATE MOFETIL	02320630	250 MG	CAPSULE · ORAL	SANDOZ CANADA INCORPORATED
TEVA-MYCOPHENOLATE	02348675	500 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-MYCOPHENOLATE	02364883	250 MG	CAPSULE · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CELLCEPT 200 MG/ML ORAL SUSP	$8.31442	per ML	23 Sep 2026
US NADAC	CELLCEPT 250 MG CAPSULE	$8.64903	per EA	23 Sep 2026
US NADAC	CELLCEPT 500 MG TABLET	$17.33941	per EA	23 Sep 2026
US NADAC	MYCOPHENOLATE 200 MG/ML SUSP	$0.98162	per ML	23 Sep 2026
US NADAC	MYCOPHENOLATE 250 MG CAPSULE	$0.13821	per EA	23 Sep 2026
US NADAC	MYCOPHENOLATE 500 MG TABLET	$0.26327	per EA	23 Sep 2026
US NADAC	MYCOPHENOLIC ACID DR 180 MG TB	$0.09959	per EA	23 Sep 2026
US NADAC	MYCOPHENOLIC ACID DR 360 MG TB	$0.22157	per EA	23 Sep 2026
US NADAC	MYFORTIC 180 MG TABLET	$7.43311	per EA	8 Jul 2026
US NADAC	MYFORTIC 360 MG TABLET	$14.9342	per EA	8 Jul 2026
NHS Drug Tariff	Mycophenolate mofetil 1g/5ml oral suspension sugar free	£115.16	160 ml	1 Oct 2026
NHS Drug Tariff	Mycophenolate mofetil 250mg capsules	£13.57	100 capsule	1 Oct 2026
NHS Drug Tariff	Mycophenolate mofetil 500mg tablets	£6.06	50 tablet	1 Oct 2026
NHS Drug Tariff	Mycophenolic acid 180mg gastro-resistant tablets	£96.72	120 tablet	1 Oct 2026
NHS Drug Tariff	Mycophenolic acid 360mg gastro-resistant tablets	£193.43	120 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 30 Jun 2025 MYFORTIC — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 12 Mar 2020 PRAC signal: Posterior reversible encephalopathy syndrome (PRES)
Action for MAH: update of the product information: No
EMA PRAC 31 Oct 2019 PRAC signal: Posterior reversible encephalopathy syndrome (PRES)
Action for MAH: update of the product information: No

All safety entries for mycophenolic acid →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.