Edarbi Takeda Pharma A/S · Authorised · authorised 7 Dec 2011 · ATC C09CA09
Therapeutic indication (EMA)
Edarbi is indicated for the treatment of essential hypertension in adults.
Active substance
Azilsartan
- SFDA 6
- EMA 2
- Health Canada 4
- US price lines 2
- NHS prices 3
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| EDARBI 40 mg tablet | 40 mg | Tablet · Oral use | 28 Blister | SAR 65.20 | NCE · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| EDARBI 80 mg tablet | 80 mg | Tablet · Oral use | 28 Blister | SAR 97.85 | NCE · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| EZEACT 40 mg Tablet | 40 mg | Tablet · Oral use | 28 Blister | SAR 65.20 | NCE · Prescription | BATTERJEE PHARMACETICAL FACTORY | Valid |
| EZEACT 80 mg Tablet | 80 mg | Tablet · Oral use | 28 Blister | SAR 97.85 | NCE · Prescription | BATTERJEE PHARMACETICAL FACTORY | Valid |
| EDARBI 40 mg tablet | 40 mg | Tablet · Oral use | 28 Blister | SAR 65.20 | NCE · Prescription | TAKEDA | Withdrawn by MAH · Not Marketed |
| EDARBI 80 mg tablet | 80 mg | Tablet · Oral use | 28 Blister | SAR 97.85 | NCE · Prescription | TAKEDA | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
CHRONIC KIDNEY DISEASE; CORONARY ARTERY DISEASE; HYPERTENSION
EMA European Union — centrally authorised medicines
Ipreziv Takeda Pharma A/S · Withdrawn · authorised 7 Dec 2011 · ATC C09CA09
Therapeutic indication (EMA)
Ipreziv is indicated for the treatment of essential hypertension in adults.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| AURO-AZILSARTAN MEDOXOMIL | 02547015 | 40 MG | TABLET · ORAL | AURO PHARMA INC |
| AURO-AZILSARTAN MEDOXOMIL | 02547023 | 80 MG | TABLET · ORAL | AURO PHARMA INC |
| EDARBI | 02381389 | 40 MG | TABLET · ORAL | BAUSCH HEALTH, CANADA INC. |
| EDARBI | 02381397 | 80 MG | TABLET · ORAL | BAUSCH HEALTH, CANADA INC. |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | AZILSARTAN MEDOXOMIL 40 MG TAB | $5.46667 | per EA | 23 Sep 2026 |
| US NADAC | AZILSARTAN MEDOXOMIL 80 MG TAB | $5.81043 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Azilsartan medoxomil 20mg tablets | £16.80 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Azilsartan medoxomil 40mg tablets | £16.80 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Azilsartan medoxomil 80mg tablets | £19.95 | 28 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
- EMA PRAC 31 Oct 2024 PRAC signal: Intestinal angioedema
Action for MAH: update of the product information: Yes
Combinations containing Azilsartan
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.