Sibnayal

RSS

potassium citrate / potassium hydrogen carbonate

Authorised
This medicine is authorised for use in the European Union.

Overview

Sibnayal is a medicine used to treat patients from the age of one year with distal renal tubular acidosis (dRTA), a disease in which the kidneys do not remove acid through the urine well enough. This results in a build-up of acid in the blood, which leads to a range of symptoms including hearing and growth problems, vomiting, kidney stones and lack of alertness. The disease also causes levels of potassium in the blood to fall, which can lead to muscle weakness and paralysis.

Sibnayal contains the active substances potassium citrate and potassium hydrogen carbonate.

This EPAR was last updated on 03/05/2021

Authorisation details

Product details
Name
Sibnayal
Agency product number
EMEA/H/C/005407
Active substance
  • Potassium citrate monohydrated
  • Potassium hydrogen carbonate
International non-proprietary name (INN) or common name
  • potassium citrate
  • potassium hydrogen carbonate
Therapeutic area (MeSH)
Acidosis, Renal Tubular
Anatomical therapeutic chemical (ATC) code
A12BA30
Publication details
Marketing-authorisation holder
Advicenne S.A.
Date of issue of marketing authorisation valid throughout the European Union
30/04/2021
Contact address

22 Rue De La Paix
75002 Paris
France

Product information

30/04/2021 Sibnayal - EMEA/H/C/005407 -

Contents

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Pharmacotherapeutic group

Mineral supplements

Therapeutic indication

Sibnayal is indicated for the treatment of distal renal tubular acidosis (dRTA) in adults, adolescents and children aged one year and older.

Assessment history

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