This brand name is authorized in Austria, Estonia, Finland, Croatia, Ireland, Israel, Japan, Lithuania, Poland, Romania, United Kingdom, United States
The drug BESREMI contains one active pharmaceutical ingredient (API):
1
Ropeginterferon alfa-2b
UNII 981TME683S - ROPEGINTERFERON ALFA-2B
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Ropeginterferon alfa-2b is a recombinant interferon alfa-2b conjugated with a two-arm mPEG at a degree of substitution of 1 mole of polymer/mole of protein. Interferon alfa belongs to the class of type I interferons which exhibit their cellular effects by binding to a transmembrane receptor termed interferon alfa receptor (IFNAR). Binding to IFNAR initiates a downstream signalling cascade through the activation of kinases, particularly Janus kinase 1 (JAK1) and tyrosine kinase 2 (TYK2) and signal transducer and activator of transcription (STAT) proteins. Interferon alfa was shown to have an inhibitory effect on the proliferation of hematopoietic and bone marrow fibroblast progenitor cells and antagonised the action of growth factors and other cytokines that have a role in the development of myelofibrosis. These actions may be involved in the therapeutic effects of interferon alfa in polycythaemia vera. |
Below package inserts are available for further reading:
Title | Information Source | Document Type | |
---|---|---|---|
BESREMI Solution for injection | European Medicines Agency (EU) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
ATC code | Group title | Classification |
---|---|---|
L03AB15 | L Antineoplastic and immunomodulating agents → L03 Immunostimulants → L03A Immunostimulants → L03AB Interferons | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
Country | Identification scheme | Identifier(s) |
---|---|---|
Country: EE | Ravimiamet | Identifier(s): 1789566, 1789577 |
Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 495597 |
Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 398863 |
Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 8762, 8763 |
Country: JP | 医薬品医療機器総合機構 | Identifier(s): 42914F1G1024, 42914F1G2020 |
Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1087061, 1087062, 1092113 |
Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100416921, 100416973 |
Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W65757001 |
Country: US | FDA, National Drug Code | Identifier(s): 73536-500 |
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