This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Spain, Turkey, UK.
The drug ENTYVIO contains one active pharmaceutical ingredient (API):
1
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UNII
9RV78Q2002 - VEDOLIZUMAB
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Vedolizumab is a gut-selective immunosuppressive biologic. It is a humanised monoclonal antibody that binds specifically to the α4β7 integrin, which is preferentially expressed on gut homing T helper lymphocytes. By binding to α4β7 on certain lymphocytes, vedolizumab inhibits adhesion of these cells to mucosal addressin cell adhesion molecule-1 (MAdCAM-1), but not to vascular cell adhesion molecule-1 (VCAM-1). |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| ENTYVIO 300 mg Powder for concentrate for solution for infusion | MPI, EU: SmPC | European Medicines Agency (EU) | |
| ENTYVIO 108 mg Solution for injection | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| L04AG05 | L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AG Monoclonal antibodies | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 10384M, 10390W, 10398G, 10415E |
| BR | Câmara de Regulação do Mercado de Medicamentos | 501115100024902 |
| CA | Health Products and Food Branch | 02436841, 02497867, 02497875 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 49-MBE-0416 |
| EE | Ravimiamet | 1648953, 1818660, 1818682, 1818693, 1818705, 1818716, 1818727 |
| ES | Centro de información online de medicamentos de la AEMPS | 114923001 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 120091, 431978 |
| FR | Base de données publique des médicaments | 66320218, 67320648, 69607230 |
| GB | Medicines & Healthcare Products Regulatory Agency | 246579, 382893, 382895, 382899, 382900, 392349 |
| HK | Department of Health Drug Office | 64101 |
| IE | Health Products Regulatory Authority | 89099, 89100 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 7558 |
| JP | 医薬品医療機器総合機構 | 2399405F1020, 23994A4G1024, 23994A4G2020 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1073084, 1091254, 1091255, 1091256, 1091257, 1091258, 1091259 |
| NL | Z-Index G-Standaard, PRK | 119288, 203262, 203270 |
| PL | Rejestru Produktów Leczniczych | 100315858, 100442278 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W61129001, W66898001, W66899001 |
| SG | Health Sciences Authority | 14950P |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699456790096 |
| US | FDA, National Drug Code | 64764-107, 64764-108, 64764-300 |
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