TYSABRI

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

Active ingredients

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

1
UNII 3JB47N2Q2P - NATALIZUMAB
 

Natalizumab is a selective adhesion-molecule inhibitor and binds to the α4-subunit of human integrins, which is highly expressed on the surface of all leukocytes, with the exception of neutrophils.

 
Read more about Natalizumab

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 TYSABRI Concentrate for solution for infusion 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
L04AG03 Natalizumab L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AG Monoclonal antibodies
Discover more medicines within L04AG03

Authorization and marketing

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

Country Identification scheme Identifier(s)
AU Pharmaceutical Benefits Scheme 9505G, 9624M
BR Câmara de Regulação do Mercado de Medicamentos 538300201159311
CA Health Products and Food Branch 02286386
EE Ravimiamet 1250840, 1843882
ES Centro de información online de medicamentos de la AEMPS 06346001
FI Lääkealan turvallisuus- ja kehittämiskeskus 056915, 069394
FR Base de données publique des médicaments 68722564
GB Medicines & Healthcare Products Regulatory Agency 106264, 396511
HK Department of Health Drug Office 61519
IL מִשְׂרַד הַבְּרִיאוּת 6128
IT Agenzia del Farmaco 037150012, 037150024
JP 医薬品医療機器総合機構 1190402A1028
LT Valstybinė vaistų kontrolės tarnyba 1031485, 1075654, 1092352
NL Z-Index G-Standaard, PRK 80934
NZ Medicines and Medical Devices Safety Authority 12660
PL Rejestru Produktów Leczniczych 100003952, 100450520
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W65148001, W67544001
SG Health Sciences Authority 14408P
TN Direction de la Pharmacie et du Médicament 10913041H
TR İlaç ve Tıbbi Cihaz Kurumu 8699783760014
US FDA, National Drug Code 64406-008
ZA Health Products Regulatory Authority 42/30.1/0765

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