OZEMPIC

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

Active ingredients

The drug OZEMPIC 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  
 OZEMPIC 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
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)
AU Pharmaceutical Benefits Scheme 12075M, 12080T
BR Câmara de Regulação do Mercado de Medicamentos 526619010010201, 526619010010301
CA Health Products and Food Branch 02471469, 02471477
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 178-MBE-0221, 190-MBE-0421
EE Ravimiamet 1764435, 1788509, 1788510, 1788521, 1788532, 1788543, 1873740, 1873751
ES Centro de información online de medicamentos de la AEMPS 1171251003, 1171251005, 117251002
FI Lääkealan turvallisuus- ja kehittämiskeskus 123895, 489034, 510642
FR Base de données publique des médicaments 61400703, 63210923, 65766192
GB Medicines & Healthcare Products Regulatory Agency 364709, 364712, 364715, 380747, 387200, 387202
HK Department of Health Drug Office 66485, 66486, 66487
IE Health Products Regulatory Authority 33700, 33701, 33702, 33703, 33704, 33705, 37706, 37707, 37708
IL מִשְׂרַד הַבְּרִיאוּת 8389, 8390, 8391
IT Agenzia del Farmaco 046128017, 046128029, 046128031, 046128043, 046128056, 046128068, 046128070, 046128082
JP 医薬品医療機器総合機構 2499418G1028, 2499418G2024, 2499418G3020, 2499418G4027
LT Valstybinė vaistų kontrolės tarnyba 1085075, 1086013, 1086014, 1086015, 1086016, 1086017
NL Z-Index G-Standaard, PRK 201650, 201677, 201693
PL Rejestru Produktów Leczniczych 100401983, 100413822, 100413839
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W65785001, W65786001, W65786002, W65787001, W65787002
TR İlaç ve Tıbbi Cihaz Kurumu 8699676950300, 8699676950317, 8699676950324, 8699676950362, 8699676950379
US FDA, National Drug Code 0169-4130, 0169-4132, 0169-4136, 50090-5138, 70518-2143

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