Combination of | |
---|---|
Potassium citrate | Mineral supplement |
Potassium hydrogen carbonate | Mineral supplement |
Clinical data | |
Trade names | Sibnayal |
Other names | ADV7103, potassium citrate/potassium hydrogencarbonate, potassium citrate/potassium bicarbonate |
Routes of administration | By mouth |
ATC code | |
Legal status | |
Legal status |
Potassium citrate/potassium hydrogen carbonate, sold under the brand name Sibnayal, is a fixed-dose combination medication intended for the treatment of distal renal tubular acidosis. [1] It contains potassium citrate and potassium hydrogen carbonate. [1]
Potassium citrate/potassium hydrogen carbonate was approved for medical use in the European Union in April 2021. [1]
Potassium citrate/potassium hydrogen carbonate is indicated for the treatment of distal renal tubular acidosis (dRTA) in people aged one year and older. [1]
In December 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Sibnayal. [1] The applicant for this medicinal product is Advicenne S.A. [1] Potassium citrate/potassium hydrogen carbonate was approved for medical use in the European Union in April 2021. [1]
Potassium citrate/potassium hydrogen carbonate is recommended for approval in the United Kingdom. [3]
Potassium citrate/potassium hydrogen carbonate is undergoing phase III trials in preparation for evaluation by the US Food and Drug Administration (FDA). [4]