TOUJEO

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

Active ingredients

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

1
UNII 2ZM8CX04RZ - INSULIN GLARGINE
 

Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH. After injection, the acidic solution is neutralised leading to formation of a precipitate from which small amounts of insulin glargine are continuously released.

 
Read more about Insulin glargine

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 TOUJEO 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
A10AE04 Insulin glargine 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 A10AE04

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 11302W, 11308E
BR Câmara de Regulação do Mercado de Medicamentos 502816010070703, 502816010070803, 576720020055617, 576720020055717
CA Health Products and Food Branch 02441829, 02493373
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 62-MBE-0716
EE Ravimiamet 1202971, 1202982, 1202993, 1203006, 1203017, 1203028, 1203039, 1203040, 1483455, 1483466, 1483477, 1483488, 1483499, 1483501, 1483512, 1483523, 1483624, 1483635, 1483646, 1483657, 1483668, 1483679, 1483680, 1483691, 1483703, 1483714, 1483725, 1483736, 1483747, 1483758, 1483769, 1483770, 1684010, 1684021, 1684043, 1728794, 1806982, 1806993, 1807006, 1807017, 1807028
ES Centro de información online de medicamentos de la AEMPS 1000133038, 100133034
FI Lääkealan turvallisuus- ja kehittämiskeskus 479186, 577406
FR Base de données publique des médicaments 62030744, 68378405
GB Medicines & Healthcare Products Regulatory Agency 298670, 369114, 381706, 389915, 393611
HK Department of Health Drug Office 64661
IE Health Products Regulatory Authority 31145, 41752, 41753
IL מִשְׂרַד הַבְּרִיאוּת 7862
IT Agenzia del Farmaco 043192018, 043192020, 043192032, 043192044, 043192057, 043192069, 043192071, 043192083, 043192095, 043192107, 043192119, 043192133, 043192145, 043192158, 043192160, 043192172, 043192184, 043192196, 043192208, 043192210, 043192222, 043192234, 043192246, 043192259, 043192261, 043192273, 043192285, 043192297, 043192309, 043192311, 043192323, 043192335, 043192347, 043192350, 043192362, 043192374, 043192386, 043192398, 043192400, 043192412, 043192424
LT Valstybinė vaistų kontrolės tarnyba 1030338, 1030339, 1030340, 1030341, 1030342, 1030343, 1030344, 1030345, 1056646, 1056647, 1056648, 1056649, 1056650, 1056651, 1056652, 1056653, 1056654, 1056655, 1056656, 1056657, 1056658, 1056659, 1056660, 1056661, 1056663, 1056664, 1056665, 1056666, 1056667, 1056668, 1056669, 1056670, 1076828, 1076829, 1076830, 1080854, 1087719, 1087720, 1087721, 1087722, 1088306
NL Z-Index G-Standaard, PRK 125652, 197521
NZ Medicines and Medical Devices Safety Authority 17846
PL Rejestru Produktów Leczniczych 100340158
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W61744001, W61744002, W61744003, W65691001
SG Health Sciences Authority 15138P
TN Direction de la Pharmacie et du Médicament 1823041
TR İlaç ve Tıbbi Cihaz Kurumu 8699809950856, 8699809950863
US FDA, National Drug Code 0024-5869, 0024-5871, 50090-4177
ZA Health Products Regulatory Authority 49/21.1/1230

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