Tolvaptan Accord (tolvaptan)
Generic
- Region
- 🇪🇺 EU
- Active substance
- tolvaptan
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Inappropriate ADH Syndrome
- CHMP opinion
- Thu 26 Jan 2023
- Designations
- Generic
- Application
- EMEA/H/C/005961
- ATC
- C03XA01
- Official record
- www.ema.europa.eu
Indication
Tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Samsca Authorised · Otsuka Pharmaceutical Netherlands B.V.
- 🇪🇺 Jinarc Authorised · Otsuka Pharmaceutical Netherlands B.V.
Follow Tolvaptan Accord
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.