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EMA Product

Jinarc

Product approved by European Medicines Agency (EU)

Basic Information

Jinarc

Regulatory Information

EMEA/H/C/002788

Authorised

May 27, 2015

February 26, 2015

23

November 20, 2024

Company Information

Netherlands

Herikerbergweg 292 1101 CT Amsterdam

Otsuka Pharmaceutical Netherlands B.V.

Drug Classification

Additional Monitoring

Active Substances Detail

Detailed Information

Therapeutic Indication

### 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.

Overview Summary

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.

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