Jinarc

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tolvaptan

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 18/06/2019

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 monitoringAdditional 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
12
Date of issue of marketing authorisation valid throughout the European Union
27/05/2015
Contact address

Herikerbergweg 292
1101 CT Amsterdam
Netherlands

Product information

10/04/2019 Jinarc - EMEA/H/C/002788 - IB/0022

Contents

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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.

Assessment history

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