TRESIBA

This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Italy, Japan, Lithuania, Netherlands, Nigeria, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

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 more about Insulin degludec

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
TRESIBA Solution for injection	MPI, EU: SmPC	European Medicines Agency (EU)
TRESIBA Solution for injection	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
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)
BR	Câmara de Regulação do Mercado de Medicamentos	526614070007702, 526614070007802, 526620010007907, 526620120008307, 526620120008407, 526620120008507, 526620120008607
CA	Health Products and Food Branch	02467879, 02467887
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	67-MBE-0816
EE	Ravimiamet	1605563, 1605574, 1605585, 1605596, 1605608, 1605619, 1605620, 1605642, 1605653, 1780310
ES	Centro de información online de medicamentos de la AEMPS	112807004, 112807013
FI	Lääkealan turvallisuus- ja kehittämiskeskus	152543, 378003, 566683
FR	Base de données publique des médicaments	60791754, 69786114
GB	Medicines & Healthcare Products Regulatory Agency	219286, 219302, 219320, 377510, 377512, 380749, 381713
HK	Department of Health Drug Office	62699, 62700
IE	Health Products Regulatory Authority	72386, 72390, 72398
IT	Agenzia del Farmaco	042658017, 042658029, 042658031, 042658043, 042658056, 042658068, 042658070, 042658082, 042658094, 049709013
JP	医薬品医療機器総合機構	2492419A1029, 2492419G1021
LT	Valstybinė vaistų kontrolės tarnyba	1069143, 1069144, 1069145, 1069146, 1069147, 1069148, 1069149, 1069150, 1069151, 1071818, 1071819, 1071820, 1071821, 1086102
NG	Registered Drug Product Database	A6-0484
Switch country to Nigeria in order to find specific presentations of TRESIBA
NL	Z-Index G-Standaard, PRK	115207, 115215, 115223
PL	Rejestru Produktów Leczniczych	100315350, 100315367
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65194001, W66105001, W66105002, W66105003, W66105004, W66105005
SG	Health Sciences Authority	15703P, 15704P
TN	Direction de la Pharmacie et du Médicament	5993131, 5993132
TR	İlaç ve Tıbbi Cihaz Kurumu	8699676951062, 8699676951079, 8699676951086, 8699676951093, 8699676951109, 8699676951116, 8699676951123, 8699676951130, 8699676951147
US	FDA, National Drug Code	0169-2550, 0169-2660, 0169-2662, 50090-3491
ZA	Health Products Regulatory Authority	47/21.1/0108, 47/21.1/0109