BESREMI

This brand name is authorized in United States. It is also authorized in Austria, Croatia, Estonia, Finland, Ireland, Israel, Japan, Lithuania, Poland, Romania, UK.

Active ingredients

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

1
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 more about Ropeginterferon alfa-2b

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group 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)
EE Ravimiamet 1789566, 1789577
FI Lääkealan turvallisuus- ja kehittämiskeskus 495597
GB Medicines & Healthcare Products Regulatory Agency 398863
IL מִשְׂרַד הַבְּרִיאוּת 8762, 8763
JP 医薬品医療機器総合機構 42914F1G1024, 42914F1G2020
LT Valstybinė vaistų kontrolės tarnyba 1087061, 1087062, 1092113
PL Rejestru Produktów Leczniczych 100416921, 100416973
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W65757001
US FDA, National Drug Code 73536-500

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