Semglee

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insulin glargine

Authorised
This medicine is authorised for use in the European Union.

Overview

An overview of Semglee and why it is authorised in the EU

Semglee is a medicine used to treat diabetes in patients from 2 years of age. It contains the active substance insulin glargine.

Semglee is a ‘biosimilar medicine’. This means that Semglee is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU.

This EPAR was last updated on 04/06/2018

Authorisation details

Product details
Name
Semglee
Agency product number
EMEA/H/C/004280
Active substance
insulin glargine
International non-proprietary name (INN) or common name
insulin glargine
Therapeutic area (MeSH)
Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code
A10AE04
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

BiosimilarBiosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Publication details
Marketing-authorisation holder
Mylan S.A.S
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
23/03/2018
Contact address

117 Allee des Parcs
69800 Saint-Priest
France

Product information

03/04/2018 Semglee - EMEA/H/C/004280 - IB/0002

Contents

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Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.

Assessment history

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