EU/3/19/2239: Orphan designation for the treatment of cystinuria

tripotassium citrate monohydrate / Potassium hydrogen carbonate

Table of contents


On 9 January 2020, orphan designation EU/3/19/2239 was granted by the European Commission to Advicenne S.A, France, for tripotassium citrate monohydrate and potassium hydrogen carbonate (also known as ADV7103) for the treatment of cystinuria.

The sponsor’s address was updated in March 2021.

Key facts

Active substance
  • tripotassium citrate monohydrate
  • Potassium hydrogen carbonate
Intended use
Treatment of cystinuria
Orphan designation status
EU designation number
Date of designation

Advicenne S.A.
22 rue de la Paix
75002 Paris
Tel. +33 4660 55420

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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