Dazparda (insulin aspart)
BiosimilarAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- insulin aspart
- Company
- Sandoz GmbH
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus
- CHMP opinion
- Thu 26 Feb 2026
- EU approval
- Mon 27 Apr 2026
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006187
- ATC
- A10AB05
- Official record
- www.ema.europa.eu
Indication
Dazparda is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Regulatory milestones
Mon 27 Apr 2026🇪🇺 EU approval (EC decision)
Dazparda (insulin aspart) approved in the EU
Marketing authorisation to Sandoz GmbH; Biosimilar, Additional monitoring · source
Thu 26 Feb 2026🇪🇺 CHMP positive opinion
Dazparda (insulin aspart): CHMP positive opinion
Sandoz GmbH; Biosimilar, Additional monitoring · source
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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.