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Truvelog Mix 30 (insulin aspart)

BiosimilarAdditional monitoring
Region
🇪🇺 EU
Active substance
insulin aspart
Company
Sanofi Winthrop Industrie
Status
Withdrawn
Therapeutic area
Diabetes Mellitus
CHMP opinion
Thu 24 Feb 2022
EU approval
Mon 25 Apr 2022
Designations
Biosimilar, Additional monitoring
Application
EMEA/H/C/005635
ATC
A10AD05
Official record
www.ema.europa.eu

Indication

Truvelog Mix 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.