RYBELSUS

This brand name is authorized in Brazil, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States

Active ingredients

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

1
UNII 53AXN4NNHX - SEMAGLUTIDE
 

Semaglutide is a GLP-1 receptor agonist. It acts in the same way as GLP-1 (a hormone produced in the gut) by increasing the amount of insulin that the pancreas releases in response to food. This helps with the control of blood glucose levels.

 
Read more about Semaglutide

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 RYBELSUS Tablet MPI, US: SPL/PLR FDA, National Drug Code (US)

Medicine classification

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

ATC Group Classification
A10BJ06 A Alimentary tract and metabolism → A10 Drugs used in diabetes → A10B Blood glucose lowering drugs, excl. insulins → A10BJ Glucagon-like peptide-1 (GLP-1) analogues
Discover more medicines within A10BJ06

Authorization and marketing

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 526620120008707, 526620120008807, 526620120008907, 526620120009007, 526620120009107, 526620120009207, 526620120009307, 526620120009407, 526620120009507, 526620120009607, 526620120009707, 526620120009807
CA Health Products and Food Branch 02497581, 02497603, 02497611
EE Ravimiamet 1815814, 1815825, 1815836, 1815847, 1815869, 1815870, 1815881, 1815892, 1815904, 1815915
ES Centro de información online de medicamentos de la AEMPS 1201430002, 1201430005, 1201430008
FI Lääkealan turvallisuus- ja kehittämiskeskus 047094, 146870, 383205, 439552, 478961
FR Base de données publique des médicaments 64596449, 66639842, 67593141
GB Medicines & Healthcare Products Regulatory Agency 387319, 387322, 387325
IL מִשְׂרַד הַבְּרִיאוּת 8786, 8787, 8788
IT Agenzia del Farmaco 048719013, 048719025, 048719037, 048719049, 048719052, 048719064, 048719076, 048719088, 048719090, 048719102, 048719114, 048719126, 048719138, 048719140, 048719153
JP 医薬品医療機器総合機構 2499014F1021, 2499014F2028, 2499014F3024
LT Valstybinė vaistų kontrolės tarnyba 1089852, 1089853, 1089854, 1089855, 1089856, 1089857, 1089858, 1089859, 1089860, 1089861, 1091558, 1091559, 1091560
NL Z-Index G-Standaard, PRK 203394, 203408, 203416
PL Rejestru Produktów Leczniczych 100434043, 100434050, 100434066
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W66741001, W66741002, W66741003, W66741004, W66742002, W66742003, W66742004, W66743001, W66743002, W66743003
TR İlaç ve Tıbbi Cihaz Kurumu 8699676011230, 8699676011247, 8699676011254, 8699676011261, 8699676011278, 8699676011285, 8699676011292, 8699676011308, 8699676011315
US FDA, National Drug Code 0169-4303, 0169-4307, 0169-4314

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