TRESIBA

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

Active ingredients

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

1 Insulin degludec
UNII 54Q18076QB - INSULIN DEGLUDEC

Insulin degludec binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin. The blood glucose-lowering effect of insulin is due to the facilitated uptake of glucose following the binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.

Read about Insulin degludec

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
TRESIBA Solution for injection European Medicines Agency (EU) MPI, EU: SmPC
TRESIBA Solution for injection FDA, National Drug Code (US) MPI, US: SPL/PLR

Medicine classification

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

ATC code Group title Classification
A10AE06 A Alimentary tract and metabolism → A10 Drugs used in diabetes → A10A Insulins and analogues → A10AE Insulins and analogues for injection, long-acting
Discover more medicines within A10AE06

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 526614070007702, 526614070007802, 526620010007907, 526620120008307, 526620120008407, 526620120008507, 526620120008607
Country: CA Health Products and Food Branch Identifier(s): 02467879, 02467887
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 67-MBE-0816
Country: EE Ravimiamet Identifier(s): 1605563, 1605574, 1605585, 1605596, 1605608, 1605619, 1605620, 1605642, 1605653, 1780310
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 112807004, 112807013
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 152543, 378003, 566683
Country: FR Base de données publique des médicaments Identifier(s): 60791754, 69786114
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 219286, 219302, 219320, 377510, 377512, 380749, 381713
Country: HK Department of Health Drug Office Identifier(s): 62699, 62700
Country: IE Health Products Regulatory Authority Identifier(s): 72386, 72390, 72398
Country: JP 医薬品医療機器総合機構 Identifier(s): 2492419A1029, 2492419G1021
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1069143, 1069144, 1069145, 1069146, 1069147, 1069148, 1069149, 1069150, 1069151, 1071818, 1071819, 1071820, 1071821, 1086102
Country: NL Z-Index G-Standaard, PRK Identifier(s): 115207, 115215, 115223
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100315350, 100315367
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W65194001, W66105001, W66105002, W66105003, W66105004, W66105005
Country: SG Health Sciences Authority Identifier(s): 15703P, 15704P
Country: TN Direction de la Pharmacie et du Médicament Identifier(s): 5993131, 5993132
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699676951062, 8699676951079, 8699676951086, 8699676951093, 8699676951109, 8699676951116, 8699676951123, 8699676951130, 8699676951147
Country: US FDA, National Drug Code Identifier(s): 0169-2550, 0169-2660, 0169-2662, 50090-3491
Country: ZA Health Products Regulatory Authority Identifier(s): 47/21.1/0108, 47/21.1/0109

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