TRESIBA

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, 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	FDA, National Drug Code (US)	MPI, US: SPL/PLR
TRESIBA 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
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: IT	Agenzia del Farmaco	Identifier(s): 042658017, 042658029, 042658031, 042658043, 042658056, 042658068, 042658070, 042658082, 042658094, 049709013
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