RESTASIS

This brand name is authorized in Brazil, Canada, Ecuador, Hong Kong, Israel, Mexico, Turkey, United States

Active ingredients

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

1 Ciclosporin
UNII 83HN0GTJ6D - CYCLOSPORINE

Ciclosporin (also known as ciclosporin A) is a cyclic polypeptide immunomodulator with immunosuppressant properties. It has been shown to prolong survival of allogeneic transplants in animals and significantly improved graft survival in all types of solid organ transplantation in man. Ciclosporin has also been shown to have an anti-inflammatory effect.

Read about Ciclosporin

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
RESTASIS Emulsion FDA, National Drug Code (US) MPI, US: SPL/PLR

Medicine classification

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

ATC code Group title Classification
L04AD01 Ciclosporin L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AD Calcineurin inhibitors
Discover more medicines within L04AD01
S01XA18 Ciclosporin S Sensory organs → S01 Ophthalmologicals → S01X Other ophthalmologicals → S01XA Other ophthalmologicals
Discover more medicines within S01XA18

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): 501005002176313
Country: CA Health Products and Food Branch Identifier(s): 02355655, 02476835
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 25.638-04-04
Country: HK Department of Health Drug Office Identifier(s): 57837
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 7088
Country: MX Comisión Federal para la Protección contra Riesgos Sanitarios Identifier(s): 484M2003
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699490546017
Country: US FDA, National Drug Code Identifier(s): 0023-5301, 0023-9163, 50090-1242, 50090-4476

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