EU/3/17/1888: Orphan designation for the treatment of distal renal tubular acidosis
tripotassium citrate monohydrate / Potassium hydrogen carbonate
Table of contents
On 20 June 2017, orphan designation (EU/3/17/1888) was granted by the European Commission to Advicenne Pharma SA, France, for tripotassium citrate monohydrate and potassium hydrogen carbonate (also known as ADV7103) for the treatment of distal renal tubular acidosis.
The sponsor’s address was updated in March 2021.
Please note that this product (marketed as Sibnayal ) was withdrawn from the Union Register of orphan medicinal products in March 2021 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.
Treatment of distal renal tubular acidosis
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Advicenne Pharma SA
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of the product at the time of marketing authorisation.
The sponsor formally requested the withdrawal of the orphan designation prior to the Committee’s final opinion. More information is available in the withdrawal assessment report – orphan maintenance .
Documents related to this orphan designation evaluation
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: