BESREMI

This brand name is authorized in Austria, Estonia, Finland, Croatia, Ireland, Israel, Japan, Lithuania, Poland, Romania, United Kingdom, United States

Active ingredients

The drug BESREMI contains one active pharmaceutical ingredient (API):

1 Ropeginterferon alfa-2b
UNII 981TME683S - ROPEGINTERFERON ALFA-2B

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.

Read about Ropeginterferon alfa-2b

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
BESREMI Solution for injection European Medicines Agency (EU) MPI, EU: SmPC

Medicine classification

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
Discover more medicines within L03AB15

Authorization and marketing

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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