Is Patiromer sorbitex registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Patiromer sorbitex, including VELTASSA 16.8G SACHET (16.8 g, Powder for oral suspension, SAR 1126.60); VELTASSA 25.2G SACHET (25.2 g, Powder for oral suspension, SAR 1219.70); VELTASSA 8.4G SACHET (8.4 g, Powder for oral suspension, SAR 1088.95).

Is Patiromer sorbitex approved by the US FDA?

Drugs@FDA lists 2 application product lines for Patiromer sorbitex, including VELTASSA (Prescription); VELTASSA (Discontinued).

Is Patiromer sorbitex authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Patiromer sorbitex: Veltassa.

Are there safety signals or safety updates for Patiromer sorbitex?

US FDA: 1 entry (latest 2023-10-02).

Active substance

Patiromer sorbitex

SFDA 3
US FDA 2
EMA 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
VELTASSA 16.8G SACHET	16.8 g	Powder for oral suspension · Oral use	30 Sachet	SAR 1126.60	NCE · Prescription	Vifor Fresenius Medical Care Renal Pharma (VFMCRP) Ltd	Valid
VELTASSA 25.2G SACHET	25.2 g	Powder for oral suspension · Oral use	30 Sachet	SAR 1219.70	NCE · Prescription	OM Pharma S.A.	Valid
VELTASSA 8.4G SACHET	8.4 g	Powder for oral suspension · Oral use	30 Sachet	SAR 1088.95	NCE · Prescription	Vifor Fresenius Medical Care Renal Pharma (VFMCRP) Ltd	Valid

Indications — CHI Daman Drug Formulary

CHRONIC KIDNEY DISEASE-HYPERKALEMIA; HYPERKALEMIA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
VELTASSA	EQ 8.4GM BASE/PACKET; EQ 16.8GM BASE/PACKET; EQ 1GM BASE/PACKET	powder · oral	VIFOR PHARMA	Prescription	21 Oct 2015
VELTASSA	EQ 25.2GM BASE/PACKET	powder · oral	VIFOR PHARMA	Discontinued	21 Oct 2015

EMA European Union — centrally authorised medicines

Veltassa Vifor Fresenius Medical Care Renal Pharma France · Authorised · authorised 19 Jul 2017 · ATC V03AE09

Therapeutic indication (EMA)

Veltassa is indicated for the treatment of hyperkalaemia in adults and adolescents aged 12 to 17 years.

Safety signals and safety-related labeling changes

US FDA 2 Oct 2023 VELTASSA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for patiromer sorbitex →

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.