Truvelog Mix 30
insulin aspart
Table of contents
Overview
Truvelog Mix 30 is an insulin medicine used to treat patients from 10 years of age who have diabetes and need insulin to keep their blood glucose (sugar) level controlled.
Truvelog Mix 30 is a ‘biosimilar medicine’. This means that Truvelog Mix 30 is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Truvelog Mix 30 is NovoMix 30. For more information on biosimilar medicines, see here.
Truvelog Mix 30 contains the active substance insulin aspart combined with protamine to make it longer acting.
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List item
Truvelog Mix 30 : EPAR - Summary for the public (PDF/120.25 KB)
First published: 15/06/2022
EMA/125308/2022 -
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List item
Truvelog Mix 30 : EPAR - Risk-management-plan summary (PDF/31.31 KB)
First published: 15/06/2022
Authorisation details
Product details | |
---|---|
Name |
Truvelog Mix 30
|
Agency product number |
EMEA/H/C/005635
|
Active substance |
insulin aspart
|
International non-proprietary name (INN) or common name |
insulin aspart
|
Therapeutic area (MeSH) |
Diabetes Mellitus
|
Anatomical therapeutic chemical (ATC) code |
A10AD05
|
Additional 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. |
Biosimilar |
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 | |
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Marketing-authorisation holder |
Sanofi Winthrop Industrie
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Revision |
1
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Date of issue of marketing authorisation valid throughout the European Union |
25/04/2022
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Contact address |
82 Avenue Raspail |
Product information
16/12/2022 Truvelog Mix 30 - EMEA/H/C/005635 - T/0001
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Drugs used in diabetes
Therapeutic indication
Truvelog Mix 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above.