RESTASIS

This brand name is authorized in United States. It is also authorized in Brazil, Canada, Ecuador, Hong Kong SAR China, Israel, Mexico, Turkey.

Active ingredients

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

1
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 more about Ciclosporin

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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

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