PROGRAF

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

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 more about Tacrolimus

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
PROGRAF Hard capsule	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)
PROGRAF Concentrate for solution for infusion	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

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

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