Jinarc
tolvaptan
Table of contents
Overview
Jinarc is a medicine used to treat adults with autosomal dominant polycystic kidney disease. This is an inherited condition in which numerous fluid-filled cysts develop in the kidneys, which eventually affect kidney function and can cause the kidneys to fail. Jinarc is for use in patients with normal to moderately reduced kidney function at the beginning of treatment with Jinarc and whose disease is progressing rapidly.
Jinarc contains the active substance tolvaptan.
-
List item
Jinarc : EPAR - Medicine overview (PDF/79.28 KB)
First published: 12/06/2015
Last updated: 31/08/2018 -
-
List item
Jinarc : EPAR - Risk-management-plan summary (PDF/131.99 KB)
First published: 12/06/2015
Last updated: 21/10/2022
Authorisation details
Product details | |
---|---|
Name |
Jinarc
|
Agency product number |
EMEA/H/C/002788
|
Active substance |
Tolvaptan
|
International non-proprietary name (INN) or common name |
tolvaptan
|
Therapeutic area (MeSH) |
Polycystic Kidney, Autosomal Dominant
|
Anatomical therapeutic chemical (ATC) code |
C03XA01
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
---|---|
Marketing-authorisation holder |
Otsuka Pharmaceutical Netherlands B.V.
|
Revision |
20
|
Date of issue of marketing authorisation valid throughout the European Union |
27/05/2015
|
Contact address |
Herikerbergweg 292 |
Product information
01/09/2022 Jinarc - EMEA/H/C/002788 - II/0036
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Diuretics
Therapeutic indication
Jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with CKD stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease.