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/195.13 KB)
First published: 12/06/2015
Last updated: 08/10/2019
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 |
14
|
Date of issue of marketing authorisation valid throughout the European Union |
27/05/2015
|
Contact address |
Product information
03/04/2020 Jinarc - EMEA/H/C/002788 - R/0027
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.