PROTOPIC

This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Spain, Tunisia, UK.

Active ingredients

The drug PROTOPIC 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
PROTOPIC 0.1% Ointment	MPI, EU: SmPC	European Medicines Agency (EU)
PROTOPIC 0.03% Ointment	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

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

ATC Group		Classification
D11AH01	Tacrolimus	D Dermatologicals → D11 Other dermatological preparations → D11A Other dermatological preparations → D11AH Agents for dermatitis, excluding corticosteroids
Discover more medicines within D11AH01

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
BR	Câmara de Regulação do Mercado de Medicamentos	541118070001617, 541118070001717, 541118070001817
CA	Health Products and Food Branch	02244148, 02244149
EE	Ravimiamet	1179840, 1179851, 1207695, 1207718, 1207729, 1207741
ES	Centro de información online de medicamentos de la AEMPS	02201001, 02201002, 02201003, 02201004
FI	Lääkealan turvallisuus- ja kehittämiskeskus	125688, 145158, 180419, 473968, 566853
FR	Base de données publique des médicaments	63213392, 67798840
GB	Medicines & Healthcare Products Regulatory Agency	33834, 33837, 33848, 33851
HK	Department of Health Drug Office	48906, 48907
IE	Health Products Regulatory Authority	55685, 57375, 58726, 66306, 66310, 66321
IL	מִשְׂרַד הַבְּרִיאוּת	4615, 4616
IT	Agenzia del Farmaco	035575036, 035575063
JP	医薬品医療機器総合機構	2699709M1028, 2699709M2024
LT	Valstybinė vaistų kontrolės tarnyba	1030480, 1030481, 1030482, 1030483, 1030484, 1030485
NL	Z-Index G-Standaard	14813319, 14813335
NL	Z-Index G-Standaard, PRK	67644, 67652
PL	Rejestru Produktów Leczniczych	100087417, 100087423
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W63162001, W63162002, W63162003, W63163001, W63163002, W63163003
SG	Health Sciences Authority	12523P, 12524P
TN	Direction de la Pharmacie et du Médicament	5823101, 5823102
US	FDA, National Drug Code	50222-203, 50222-211