Sibnayal (potassium citrate;potassium hydrogen carbonate)
- Region
- 🇪🇺 EU
- Active substance
- potassium citrate;potassium hydrogen carbonate
- Company
- Advicenne S.A.
- Status
- Authorised
- Therapeutic area
- Acidosis, Renal Tubular
- CHMP opinion
- Thu 10 Dec 2020
- EU approval
- Fri 30 Apr 2021
- Application
- EMEA/H/C/005407
- ATC
- A12BA30
- Official record
- www.ema.europa.eu
Indication
Sibnayal is indicated for the treatment of distal renal tubular acidosis (dRTA) in adults, adolescents and children aged one year and older.
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.