Tolvaptan Accord
Opinion
On 26 January 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tolvaptan Accord, intended for the treatment of low blood sodium levels in adults secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH). The applicant for this medicinal product is Accord Healthcare S.L.U.
Tolvaptan Accord will be available as 7.5 mg, 15 mg and 30 mg tablets. The active substance of Tolvaptan Accord is tolvaptan, a diuretic and vasopressin antagonist (ATC code: C03XA01). By blocking the vasopressin V2 receptor, tolvaptan increases urine production, resulting in a decrease in the amount of water in the blood and an increase of the blood sodium level.
Tolvaptan Accord is a generic of Samsca, which has been authorised in the EU since 03 August 2009. Studies have demonstrated the satisfactory quality of Tolvaptan Accord, and its bioequivalence to the reference product Samsca. A question and answer document on generic medicines can be found here.
The full indication is:
Tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Due to the need for a dose titration phase with close monitoring of serum sodium and volume status, treatment with tolvaptan has to be initiated in hospital.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
Key facts
| Name |
Tolvaptan Accord |
| Agency product number |
EMEA/H/C/005961 |
| International non-proprietary name (INN) or common name |
|
| Active substance |
|
| Therapeutic area |
Inappropriate ADH Syndrome
|
| Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
| Date opinion adopted |
26/01/2023 |
| Company name | |
| Status |
Positive |
| Application type |
Initial authorisation |