| Active ingredient (INN) | Tolvaptan |
|---|---|
| Brand names | Tolvaptan Biogaran |
| ATC level 5 | C03XA01 |
| ATC level 4 | C03XA |
| Therapeutic category | Auto-created by Agence nationale de sécurité du médicament — Disponibilité scraper |
| Controlled substance | No |
| Marketing-authorisation holders | Otsuka Australia Pharmaceutical Pty Ltd, Camber Pharmaceuticals, Inc., Ascend Laboratories, LLC, Lupin Pharmaceuticals, Inc. +2 more |
| Registrations on file | 10 |
| Patient information leaflet (PIL) | Not on file |
| Summary of product characteristics (SPC) | Not on file |
| Product | Strength | Form | Market | MA holder | Status |
|---|---|---|---|---|---|
| SAMSCA tolvaptan | 30 mg | — | 🇦🇺 AU | Otsuka Australia Pharmaceutical Pty Ltd | Active |
| SAMSCA tolvaptan | 15 mg | — | 🇦🇺 AU | Otsuka Australia Pharmaceutical Pty Ltd | Active |
| JINARC tolvaptan | 30 mg | — | 🇦🇺 AU | Otsuka Australia Pharmaceutical Pty Ltd | Active |
| JINARC tolvaptan | 15 mg | — | 🇦🇺 AU | Otsuka Australia Pharmaceutical Pty Ltd | Active |
| Tolvaptan | 15mg/1 | tablet | 🇺🇸 US | Camber Pharmaceuticals, Inc. | Active |
| Tolvaptan | 30mg/1 | tablet | 🇺🇸 US | Camber Pharmaceuticals, Inc. | Active |
| Tolvaptan | 60mg/1 | tablet | 🇺🇸 US | Ascend Laboratories, LLC | Active |
| TOLVAPTAN | — | kit | 🇺🇸 US | Lupin Pharmaceuticals, Inc. | Active |
| Tolvaptan Accord | — | — | 🌐 EU | Accord Healthcare S.L.U. | Active |
| Lupin-Tolvaptan | — | tablet | 🇨🇦 CA | LUPIN PHARMA CANADA LIMITED | Active |