Truvelog Mix 30


insulin aspart

This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 06/07/2023

Authorisation details

Product details
Truvelog Mix 30
Agency product number
Active substance
insulin aspart
International non-proprietary name (INN) or common name
insulin aspart
Therapeutic area (MeSH)
Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code
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.


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
Sanofi Winthrop Industrie
Date of issue of marketing authorisation valid throughout the European Union
Contact address

82 Avenue Raspail
94250 Gentilly

Product information

06/07/2023 Truvelog Mix 30 - EMEA/H/C/005635 - N/0004

Other EU languages available icon 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:

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.

Assessment history

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