PROTOPIC

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

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 about Tacrolimus

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
PROTOPIC 0.03% Ointment	European Medicines Agency (EU)	MPI, EU: SmPC
PROTOPIC 0.1% Ointment	European Medicines Agency (EU)	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
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)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 541118070001617, 541118070001717, 541118070001817
Country: CA	Health Products and Food Branch	Identifier(s): 02244148, 02244149
Country: EE	Ravimiamet	Identifier(s): 1179840, 1179851, 1207695, 1207718, 1207729, 1207741
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 02201001, 02201002, 02201003, 02201004
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 125688, 145158, 180419, 473968, 566853
Country: FR	Base de données publique des médicaments	Identifier(s): 63213392, 67798840
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 33834, 33837, 33848, 33851
Country: HK	Department of Health Drug Office	Identifier(s): 48906, 48907
Country: IE	Health Products Regulatory Authority	Identifier(s): 55685, 57375, 58726, 66306, 66310, 66321
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 4615, 4616
Country: IT	Agenzia del Farmaco	Identifier(s): 035575036, 035575063
Country: JP	医薬品医療機器総合機構	Identifier(s): 2699709M1028, 2699709M2024
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1030480, 1030481, 1030482, 1030483, 1030484, 1030485
Country: NL	Z-Index G-Standaard	Identifier(s): 14813319, 14813335
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 67644, 67652
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100087417, 100087423
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W63162001, W63162002, W63162003, W63163001, W63163002, W63163003
Country: SG	Health Sciences Authority	Identifier(s): 12523P, 12524P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 5823101, 5823102
Country: US	FDA, National Drug Code	Identifier(s): 50222-203, 50222-211