This brand name is authorized in Austria, Croatia, Cyprus, Estonia, Finland, France, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, Spain, Tunisia, UK.
The drug GAZYVARO contains one active pharmaceutical ingredient (API):
1
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UNII
O43472U9X8 - OBINUTUZUMAB
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Obinutuzumab is a recombinant monoclonal humanised and glycoengineered Type II anti-CD20 antibody of the IgG1 isotype. It specifically targets the extracellular loop of the CD20 transmembrane antigen on the surface of non-malignant and malignant pre-B and mature B-lymphocytes. Glycoengineering of the Fc part of obinutuzumab results in higher affinity for FcγRIII receptors on immune effector cells such as natural killer cells, macrophages and monocytes as compared to non-glycoengineered antibodies. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| GAZYVARO Concentrate for solution for infusion | 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 | |
|---|---|---|
| L01FA03 | Obinutuzumab | L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FA CD20 (Clusters of Differentiation 20) inhibitors |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| EE | Ravimiamet | 1657133 |
| ES | Centro de información online de medicamentos de la AEMPS | 114937001, 114937001IP |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 439579 |
| FR | Base de données publique des médicaments | 61042996 |
| GB | Medicines & Healthcare Products Regulatory Agency | 254445, 383727 |
| IT | Agenzia del Farmaco | 043533013 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1073957 |
| NL | Z-Index G-Standaard, PRK | 118478 |
| PL | Rejestru Produktów Leczniczych | 100325911 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W64380001 |
| TN | Direction de la Pharmacie et du Médicament | 6993231H |
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