MYFORTIC

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug MYFORTIC contains one active pharmaceutical ingredient (API):

1 Mycophenolic acid
UNII WX877SQI1G - MYCOPHENOLATE SODIUM

Mycophenolic acid is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. Mycophenolic acid has more potent cytostatic effects on lymphocytes than on other cells and is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants.

Read about Mycophenolic acid

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
MYFORTIC Gastro-resistant tablet Medicines & Healthcare Products Regulatory Agency (GB) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
L04AA06 Mycophenolic acid L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AA Selective immunosuppressants
Discover more medicines within L04AA06

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: AU Pharmaceutical Benefits Scheme Identifier(s): 2150E, 2193K, 6369F, 6370G, 9503E, 9504F
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 526511001113213, 526511002111214
Country: CA Health Products and Food Branch Identifier(s): 02264560, 02264579
Country: DE Bundesinstitut für Arzneimittel und Medizinprodukte Identifier(s): 00080051, 00081197, 00361057, 00361063, 00361086, 00445771, 01755321, 01755338, 01755396, 01755404, 02251858, 05395919, 05481091, 06733086, 06733092, 06733100, 06735010, 06735027, 06735033, 06799286, 08446534, 08446563, 08446586, 09264290, 09264309, 10738304, 10738310, 10738327, 10813460, 10813477, 11369895, 11369903, 11645817, 11645823, 12500392, 15612387, 15877878, 16701503, 16811953, 16812361, 17448124, 17562831, 17562848, 17845693
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 25.142-05-03, 25.143-05-03, 4623-MEE-0319, 4626-MEE-0319
Country: EE Ravimiamet Identifier(s): 1164619, 1164620, 1164631, 1164642, 1164653, 1164675, 1164686, 1164697, 1738043
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 66140, 66141
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 015722, 015744
Country: FR Base de données publique des médicaments Identifier(s): 67858369, 69678277
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 80776, 80779
Country: HK Department of Health Drug Office Identifier(s): 51396, 51397, 65402, 65403
Country: HR Agencija za lijekove i medicinske proizvode Identifier(s): HR-H-505070647, HR-H-950094160
Country: IE Health Products Regulatory Authority Identifier(s): 88719, 88725
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 4698, 4699
Country: IT Agenzia del Farmaco Identifier(s): 036511032, 036511069
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1004964, 1017717, 1017718, 1017719, 1017720, 1017721, 1017723, 1017724, 1021384, 1070336
Country: MT Medicines Authority Identifier(s): MA1249/00301, MA1249/00302, PI565/78501A
Country: MX Comisión Federal para la Protección contra Riesgos Sanitarios Identifier(s): 070M2003
Country: NL Z-Index G-Standaard, PRK Identifier(s): 74942, 74950
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 10595, 10596
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100136417, 100136742
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W42264001, W42264002, W42264003, W42264004, W42265001, W42265002, W42265003, W42265004
Country: SG Health Sciences Authority Identifier(s): 12376P, 12377P
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699504040050, 8699504040104
Country: US FDA, National Drug Code Identifier(s): 0078-0385, 0078-0386
Country: ZA Health Products Regulatory Authority Identifier(s): 37/34/0158, 37/34/0159

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