PROGRAF

This brand name is authorized in Albania, Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Malta, Mexico, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

Active ingredients

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

1 Tacrolimus UNII WM0HAQ4WNM - TACROLIMUS

Tacrolimus is a highly potent immunosuppressive agent. In particular, tacrolimus inhibits the formation of cytotoxic lymphocytes, which are mainly responsible for graft rejection. Tacrolimus suppresses T-cell activation and T-helper-cell dependent B-cell proliferation, as well as the formation of lymphokines (such as interleukins-2, -3, and γ-interferon) and the expression of the interleukin-2 receptor. Read about Tacrolimus

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
PROGRAF Hard capsule	Medicines & Healthcare Products Regulatory Agency (GB)	MPI, EU: SmPC
PROGRAF Concentrate for solution for infusion	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
L04AD02	Tacrolimus	L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AD Calcineurin inhibitors
Discover more medicines within L04AD02

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: AL	Fondi i Sigurimit të Detyrueshëm të Kujdesit Shëndetësor	Identifier(s): 452/191, 453/191
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 6216E, 6217F, 6328C, 8646C, 8647D, 8648E, 9558C, 9560E, 9561F
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 540315030002817, 540315030002917, 540315030003017, 540315030003117, 540315030003217
Country: CA	Health Products and Food Branch	Identifier(s): 02175983, 02175991, 02176009, 02243144
Country: EE	Ravimiamet	Identifier(s): 1428128, 1458299, 1615687, 1655984, 1782378, 1789050, 1790287, 1808984, 1828942, 1861095, 1864807
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 61004, 61005, 61006, 63189
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 000570, 376483, 376509, 376533
Country: FR	Base de données publique des médicaments	Identifier(s): 61217812, 63395596, 66737795, 68330403
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 139477, 139480, 175891, 175894, 180658, 180659, 23676, 23682, 23684, 23686, 368094, 368218, 373446, 373447, 373474, 373478, 373640, 376986, 379936, 379939, 392393, 392395, 43914
Country: HK	Department of Health Drug Office	Identifier(s): 41915, 41916, 41917, 47471
Country: HR	Agencija za lijekove i medicinske proizvode	Identifier(s): HR-H-183082437, HR-H-863925022, HR-H-896261915
Country: IE	Health Products Regulatory Authority	Identifier(s): 88240, 88241, 88242, 88243, 88992, 89125
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6132, 6133, 6134, 8689
Country: IT	Agenzia del Farmaco	Identifier(s): 029485048, 029485075, 029485099
Country: JP	医薬品医療機器総合機構	Identifier(s): 3999014D1022, 3999014D2029, 3999014M1022, 3999014M2029, 3999014M3025, 3999416A1028, 3999416A2024
Country: MT	Medicines Authority	Identifier(s): MA1387/00201, MA1387/00202, MA1387/00203, MA1387/00204
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 055M2016, 323M98
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100089876, 100089882, 100138474, 100195762
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W53729001, W53729002, W53730001, W53730002, W53731001, W53731002
Country: SG	Health Sciences Authority	Identifier(s): 09639P, 09649P, 09650P, 11451P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 6653411H, 6653412H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699043890321, 8699043890338, 8699043890345, 8699043890352
Country: US	FDA, National Drug Code	Identifier(s): 0469-0607, 0469-0617, 0469-0657, 0469-1230, 0469-1330, 0469-3016
Country: ZA	Health Products Regulatory Authority	Identifier(s): 32/34/0559, 32/34/0560, 32/34/0561