Potassium citrate/potassium hydrogen carbonate
| Combination of | |
|---|---|
| Potassium citrate | Mineral supplement |
| Potassium hydrogencarbonate | Mineral supplement |
| Clinical data | |
| Trade names | Sibnayal |
| Other names | ADV7103 |
| License data | |
| ATC code | |
| Legal status | |
| Legal status |
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Potassium citrate/potassium hydrogencarbonate is a fixed-dose combination medication intended for the treatment of distal renal tubular acidosis.[1] It contains potassium citrate and potassium hydrogencarbonate.[1]
Potassium citrate/potassium hydrogencarbonate was approved for medical use in the European Union in April 2021.[1]
Medical uses
Potassium citrate/potassium hydrogencarbonate is indicated for the treatment of distal renal tubular acidosis (dRTA) in people aged one year and older.[1]
History
On 10 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 hydrogencarbonate was approved for medical use in the European Union in April 2021.[1]
Potassium citrate/potassium hydrogencarbonate is recommended for approval in the United Kingdom.[2]
Research
Potassium citrate/potassium hydrogencarbonate is undergoing Phase III trials in preparation for evaluation by the U.S. Food and Drug Administration (FDA).[3]
References
- ^ a b c d e f g h "Sibnayal EPAR". European Medicines Agency (EMA). 9 December 2020. Retrieved 22 May 2021. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ "Potassium bicarbonate + potassium citrate". SPS - Specialist Pharmacy Service. 19 February 2021. Retrieved 22 May 2021.
- ^ "Advicenne receives positive feedback from the US FDA on pathway to approval and amended Phase III study protocol for its treatment of distal renal tubular acidosis (dRTA)" (Press release). Advicenne. 17 May 2021. Retrieved 22 May 2021 – via GlobeNewswire.
External links
- "Potassium citrate". Drug Information Portal. U.S. National Library of Medicine.
- "Potassium bicarbonate". Drug Information Portal. U.S. National Library of Medicine.
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