EU/3/17/1888: Orphan designation for the treatment of distal renal tubular acidosis

tripotassium citrate monohydrate / Potassium hydrogen carbonate


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Please note that this product (marketed as Sibnayal ) was withdrawn from the Union Register of orphan medicinal products in March 2021 upon request of the marketing authorisation holder at the time of the granting of a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.

Key facts

Active substance
  • tripotassium citrate monohydrate
  • Potassium hydrogen carbonate
Intended use
Treatment of distal renal tubular acidosis
Orphan designation status
EU designation number
Date of designation

Advicenne Pharma SA
22 rue de la Paix
75002 Paris
Tel. +33 4660 55420

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 PDF icon withdrawal assessment report – orphan maintenance .

Documents related to this orphan designation evaluation

Patients' organisations

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:

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