EU/3/13/1175: Orphan designation for the treatment of autosomal dominant polycystic kidney disease
Tolvaptan
Table of contents
Overview
Please note that this product (marketed as Jinarc) was withdrawn from the Community Register of designated orphan medicinal products in March 2015 upon request of the marketing authorisation holder at the time of the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
|
Intended use |
Treatment of autosomal dominant polycystic kidney disease
|
Orphan designation status |
Withdrawn
|
EU designation number |
EU/3/13/1175
|
Date of designation |
05/08/2013
|
Sponsor |
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 |
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Please note that this product (marketed as Jinarc) was withdrawn from the Community Register of designated orphan medicinal products in March 2015 upon request of the marketing authorisation holder at the time of the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.
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.
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: