This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.
The drug SIMULECT contains one active pharmaceutical ingredient (API):
1
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UNII
9927MT646M - BASILIXIMAB
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Basiliximab is a murine/human chimeric monoclonal antibody (IgG1κ) that is directed against the interleukin-2 receptor α-chain (CD25 antigen), which is expressed on the surface of T-lymphocytes in response to antigenic challenge. Basiliximab specifically binds with high affinity (KD-value 0.1 nM) to the CD25 antigen on activated T-lymphocytes expressing the high affinity interleukin-2 receptor (IL-2R) and thereby prevents binding of interleukin-2, a critical signal for T-cell proliferation in the cellular immune response involved in allograft rejection. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| SIMULECT Powder and solvent for solution for injection/infusion / Powder for solution for injection or infusion | MPI, EU: SmPC | European Medicines Agency (EU) | |
| Simulect 10mg and 20mg powder and solvent for solution for injection or infusion | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| L04AC02 | Basiliximab | L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AC Interleukin inhibitors |
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 | 526513901154419, 526518070093607 |
| CA | Health Products and Food Branch | 02242815 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 22.508-1-03-06 |
| EE | Ravimiamet | 1040117, 1210059 |
| ES | Centro de información online de medicamentos de la AEMPS | 98084001 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 013783, 522706 |
| FR | Base de données publique des médicaments | 68944294, 69890052 |
| GB | Medicines & Healthcare Products Regulatory Agency | 47735, 50079 |
| HK | Department of Health Drug Office | 44725 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 7006 |
| IT | Agenzia del Farmaco | 034232013 |
| JP | 医薬品医療機器総合機構 | 6399418D1032, 6399418D2020 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1006242, 1030800, 1074720 |
| NL | Z-Index G-Standaard | 14233746, 14884755 |
| NL | Z-Index G-Standaard, PRK | 51330, 69876 |
| NZ | Medicines and Medical Devices Safety Authority | 8188 |
| PL | Rejestru Produktów Leczniczych | 100125626, 100316148 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W64598001 |
| SG | Health Sciences Authority | 10441P |
| TN | Direction de la Pharmacie et du Médicament | 1243051H |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699504790405 |
| US | FDA, National Drug Code | 0078-0331, 0078-0393 |
| ZA | Health Products Regulatory Authority | 32/30.4/0752 |
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