Jinarc (tolvaptan)
- Region
- 🇪🇺 EU
- Active substance
- tolvaptan
- Company
- Otsuka Pharmaceutical Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Polycystic Kidney, Autosomal Dominant
- CHMP opinion
- Thu 26 Feb 2015
- EU approval
- Wed 27 May 2015
- Application
- EMEA/H/C/002788
- ATC
- C03XA01
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Tolvaptan Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Samsca Authorised · Otsuka Pharmaceutical Netherlands B.V.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.