Tolvaptan Accord Accord Healthcare S.L.U. · Authorised · ATC C03XA01
Therapeutic indication (EMA)
Tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Active substance
Tolvaptan
- SFDA 11
- US FDA 12
- EMA 3
- Health Canada 12
- US price lines 1
- NHS prices 1
- Safety 6
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Prokitav | 45+15 mg | Tablet · Oral use | 56 Blister | SAR 20397.95 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Prokitav | 30 + 60 mg | Tablet · Oral use | 56 Blister | SAR 20397.95 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Prokitav | 30 + 90 mg | Tablet · Oral use | 56 Blister | SAR 20397.95 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Salitav | 15 mg | Tablet · Oral use | 10 Blister | SAR 3642.50 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Salitav | 30 mg | Tablet · Oral use | 10 Blister | SAR 3642.50 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Vaprena | 30 mg | Tablet · Oral use | 10 Blister | SAR 3834.20 | Generic · Prescription | SPIMACO | Valid |
| Vaprena | 15 mg | Tablet · Oral use | 10 Blister | SAR 3834.20 | Generic · Prescription | SPIMACO | Valid |
| Vaprena | 30 mg | Tablet · Oral use | 90 Blister | SAR 34507.80 | Generic · Prescription | Saudi Pharmaceutical Industries & Medical Appliances Corporation | Valid |
| Vaprena | 30 mg | Tablet · Oral use | 120 Blister | SAR 46010.40 | Generic · Prescription | Saudi Pharmaceutical Industries & Medical Appliances Corporation | Valid |
| Vaprena | 15 mg | Tablet · Oral use | 60 Blister | SAR 23005.20 | Generic · Prescription | Saudi Pharmaceutical Industries & Medical Appliances Corporation | Valid |
| Vaprena | 15 mg | Tablet · Oral use | 120 Blister | SAR 46010.40 | Generic · Prescription | Saudi Pharmaceutical Industries & Medical Appliances Corporation | Valid |
Indications — CHI Daman Drug Formulary
LIVER CIRRHOSIS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| SAMSCA | 15MG; 30MG | tablet · oral | OTSUKA | Prescription | 19 May 2009 |
| JYNARQUE | 15MG; 30MG; 45MG; 60MG; 90MG | tablet · oral | OTSUKA | Prescription | 23 Apr 2018 |
| TOLVAPTAN | 30MG; 15MG | tablet · oral | APOTEX | Prescription | 19 May 2020 |
| TOLVAPTAN | 30MG; 60MG; 15MG | tablet · oral | ALKEM LABS LTD | Prescription | 19 May 2020 |
| TOLVAPTAN | 30MG; 15MG | tablet · oral | HETERO LABS LTD V | Prescription | 16 Jul 2021 |
| TOLVAPTAN | 15MG; 30MG | tablet · oral | PH HEALTH | Prescription | 15 Feb 2022 |
| TOLVAPTAN | 15MG; 30MG | tablet · oral | MSN | Prescription | 21 Jun 2023 |
| TOLVAPTAN | 15MG; 30MG; 45MG; 60MG; 90MG | tablet · oral | LUPIN | Prescription | 23 Apr 2025 |
| TOLVAPTAN | 15MG; 30MG; 45MG; 60MG; 90MG | tablet · oral | APOTEX | Prescription | 10 Nov 2025 |
| TOLVAPTAN | 15MG; 30MG; 45MG; 60MG; 90MG | tablet · oral | ALKEM LABS LTD | Prescription | 21 Apr 2026 |
| TOLVAPTAN | 15MG; 30MG; 45MG; 60MG; 90MG | tablet · oral | TEVA PHARMS INC | Prescription | 21 Jul 2026 |
| SAMSCA | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | OTSUKA | Discontinued | 19 May 2009 |
EMA European Union — centrally authorised medicines
Samsca Otsuka Pharmaceutical Netherlands B.V. · Authorised · authorised 2 Aug 2009 · ATC C03XA01
Therapeutic indication (EMA)
Treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic-hormone secretion (SIADH).
Jinarc Otsuka Pharmaceutical Netherlands B.V. · Authorised · authorised 27 May 2015 · ATC C03XA01
Therapeutic indication (EMA)
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.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| JINARC | 02437503 | 15 MG; 45 MG | TABLET · ORAL | OTSUKA PHARMACEUTICAL CO LTD |
| JINARC | 02437511 | 30 MG; 60 MG | TABLET · ORAL | OTSUKA PHARMACEUTICAL CO LTD |
| JINARC | 02437538 | 30 MG; 90 MG | TABLET · ORAL | OTSUKA PHARMACEUTICAL CO LTD |
| JINARC | 02491575 | 15 MG | TABLET · ORAL | OTSUKA PHARMACEUTICAL CO LTD |
| JINARC | 02491583 | 15 MG; 30 MG | TABLET · ORAL | OTSUKA PHARMACEUTICAL CO LTD |
| LUPIN-TOLVAPTAN | 02557177 | 15 MG | TABLET · ORAL | LUPIN PHARMA CANADA LIMITED |
| LUPIN-TOLVAPTAN | 02557185 | 15 MG; 30 MG | TABLET · ORAL | LUPIN PHARMA CANADA LIMITED |
| LUPIN-TOLVAPTAN | 02557193 | 45 MG; 15 MG | TABLET · ORAL | LUPIN PHARMA CANADA LIMITED |
| LUPIN-TOLVAPTAN | 02557207 | 30 MG; 60 MG | TABLET · ORAL | LUPIN PHARMA CANADA LIMITED |
| LUPIN-TOLVAPTAN | 02557215 | 90 MG; 30 MG | TABLET · ORAL | LUPIN PHARMA CANADA LIMITED |
| SAMSCA | 02370468 | 15 MG | TABLET · ORAL | OTSUKA PHARMACEUTICAL CO LTD |
| SAMSCA | 02370476 | 30 MG | TABLET · ORAL | OTSUKA PHARMACEUTICAL CO LTD |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | TOLVAPTAN 15 MG TABLET | $14.57406 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Tolvaptan 7.5mg tablets | £448.08 | 10 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 15 Sep 2026 JYNARQUE — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Apr 2021 SAMSCA — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - MHRA 11 Dec 2014 Tolvaptan (Samsca▼): risk of liver injury
liver-function testing recommended in patients with symptoms that may indicate liver injury. - MHRA 11 Dec 2014 Tolvaptan (Samsca▼): over-rapid increase in serum sodium risking serious neurological events
Careful monitoring of serum sodium important, co-administration of other drugs that may increase serum sodium not recommended. - EMA PRAC 7 Feb 2013 PRAC signal: Serious liver injury associated with high dose tolvaptan in patients with polycystic kidney disease
Action for MAH: update of the product information: Yes - EMA PRAC 31 Oct 2012 PRAC signal: Dehydration
Action for MAH: update of the product information: Yes
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.