EU/3/13/1175

About

Please note that this product (marketed as Jinarc) was withdrawn from the Community Register of designated orphan medicinal products in March 2015 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.

On 5 August 2013, orphan designation (EU/3/13/1175) was granted by the European Commission to Otsuka Pharmaceutical Europe Ltd, United Kingdom, for tolvaptan for the treatment of autosomal dominant polycystic kidney disease.

Key facts

Active substance
Tolvaptan
Disease / condition
Treatment of autosomal dominant polycystic kidney disease
Date of first decision
05/08/2013
Outcome
Withdrawn
EU designation number
EU/3/13/1175

Review of designation

Please note that this product (marketed as Jinarc) was withdrawn from the Community Register of designated orphan medicinal products in March 2015 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.

Sponsor's contact details

Otsuka Pharmaceutical Europe Ltd
Gallions
Wexham Springs
Framewood Road
Wexham SL3 6PJ
United Kingdom
Tel. +44 (0)1895 207100
Fax +44 (0)1895 207115
E-mail: med.affairs@otsuka-europe.com

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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