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, Turkey, UK.
The drug SYNAGIS contains one active pharmaceutical ingredient (API):
1
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UNII
DQ448MW7KS - PALIVIZUMAB
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Palivizumab is a humanised IgG1κ monoclonal antibody directed to an epitope in the A antigenic site of the fusion protein of respiratory syncytial virus (RSV). This humanised monoclonal antibody is composed of human (95%) and murine (5%) antibody sequences. It has potent neutralising and fusion-inhibitory activity against both RSV subtype A and B strains. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| SYNAGIS 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 | |
|---|---|---|
| J06BD01 | Palivizumab | J Antiinfectives for systemic use → J06 Immune sera and immunoglobulins → J06B Immunoglobulins → J06BD Antiviral monoclonal antibodies |
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 | 502321080034717, 502321080034817, 543714100000318, 543714100000418 |
| CA | Health Products and Food Branch | 02438364, 02438372 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 44-MBE-0116 |
| EE | Ravimiamet | 1141221, 1141232, 1662678, 1662689 |
| ES | Centro de información online de medicamentos de la AEMPS | 199117003, 199117004 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 379856, 536087 |
| FR | Base de données publique des médicaments | 67810869, 68932534 |
| GB | Medicines & Healthcare Products Regulatory Agency | 302514, 302517 |
| HK | Department of Health Drug Office | 64445, 64446 |
| IE | Health Products Regulatory Authority | 88557, 88563 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 8947, 8948 |
| IT | Agenzia del Farmaco | 034529014, 034529026, 034529038, 034529040 |
| JP | 医薬品医療機器総合機構 | 6250404A1020, 6250404A2026 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1030810, 1030812, 1059513, 1074856, 1089017 |
| NL | Z-Index G-Standaard, PRK | 126012, 126020 |
| NZ | Medicines and Medical Devices Safety Authority | 17462, 17463 |
| PL | Rejestru Produktów Leczniczych | 100095807, 100095813, 100326840, 100461498 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W67584001, W67585001 |
| SG | Health Sciences Authority | 11256P, 15112P |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699786770911, 8699786770928 |
| US | FDA, National Drug Code | 60574-4113, 60574-4114 |
| ZA | Health Products Regulatory Authority | 34/30.2/0240, 34/30.2/0241, 50/30.1/0148 |
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