Inpremzia (insulin human (rDNA))
BiosimilarAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- insulin human (rDNA)
- Company
- Baxter Holding B.V.
- 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- Withdrawn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/005331
- ATC
- A10AB01
- Official record
- www.ema.europa.eu
Indication
Inpremzia is indicated for the treatment of diabetes mellitus.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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- 🇪🇺 Protaphane Authorised · Novo Nordisk A/S
- 🇪🇺 Velosulin Withdrawn · Novo Nordisk A/S
- 🇪🇺 Monotard Withdrawn · Novo Nordisk A/S
- 🇪🇺 Ultratard Withdrawn · Novo Nordisk A/S
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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.