Basic Information
Semglee
Regulatory Information
EMEA/H/C/004280
Authorised
March 23, 2018
January 25, 2018
10
September 22, 2023
Company Information
Ireland
Unit 35/36 Grange Parade, Baldoyle Industrial Estate Dublin 13 DUBLIN D13 R20R
Biosimilar Collaborations Ireland Ltd.
Drug Classification
Biosimilar Medicine
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Overview Summary
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.