SEMGLEE

This brand name is authorized in United States. It is also authorized in Australia, Croatia, Ecuador, Estonia, France, Ireland, Italy, Lithuania, New Zealand, Poland, Romania, Spain, UK.

Active ingredients

The drug SEMGLEE 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  
 SEMGLEE 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
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 11815W
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 179-MBE-0221, 237-MBE-1022
EE Ravimiamet 1768091, 1768103, 1768114, 1793257
ES Centro de información online de medicamentos de la AEMPS 1181270003
FR Base de données publique des médicaments 60408661
GB Medicines & Healthcare Products Regulatory Agency 360830, 391978
IT Agenzia del Farmaco 046350017, 046350029, 046350031, 046350043, 046350056
LT Valstybinė vaistų kontrolės tarnyba 1085343, 1085344, 1085345, 1088580, 1088581
NZ Medicines and Medical Devices Safety Authority 20004
PL Rejestru Produktów Leczniczych 100405550
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W64292001, W64292002, W64292003
US FDA, National Drug Code 49502-195, 49502-196

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