Apidra (insulin glulisine)
- Region
- 🇪🇺 EU
- Active substance
- insulin glulisine
- Company
- sanofi-aventis Deutschland GmbH
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus
- CHMP opinion
- Thu 03 Jun 2004
- EU approval
- Mon 27 Sep 2004
- Application
- EMEA/H/C/000557
- ATC
- A10AB06
- Official record
- www.ema.europa.eu
Indication
Treatment of adults, adolescents and children, six years or older with diabetes mellitus, where treatment with insulin is required.
Regulatory milestones
No milestones recorded in the last year.
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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.