Table 1. Eligibility criteria for the approved use of tolvaptan according to country or region.
| Country | Chronic
kidney disease stage |
Disease activity | Regulatory body | Approval date | Guidance (if any) |
|---|---|---|---|---|---|
| Japan | 1–4 | TKV >750 ml
ΔTKV >5% per annum |
Pharmaceuticals and
Medical Devices Agency |
March 2014 | |
| Canada | Not specified | Not specified | Health Canada | February 2015 | |
| Europe | 1–3 | Evidence of
rapid disease progression |
European Medicines
Agency |
May 2015 | European Renal
Association-European Dialysis and Transplant Association |
| England, Wales,
and Northern Ireland |
2–3 | Evidence of
rapid disease progression |
National Institute for Health
and Clinical Excellence (NICE) |
October 2015 | Renal Association |
| South Korea | 1–3 | Evidence of
rapid disease progression |
Ministry of Food and Drug
Safety/Health Insurance Review and Assessment Service |
December 2015 | |
| Scotland | 1–3 | Evidence of
rapid disease progression |
Scottish Medicines
Consortium |
January 2016 | Renal Association |
TKV, total kidney volume.