Is Telmisartan registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Telmisartan, including MICARDIS 40 MG TAB (40 mg, Tablet, SAR 49.60); MICARDIS 80 MG TAB (80 mg, Tablet, SAR 65.95); NIZORTAN 40 mg Tablet (40 mg, Tablet, SAR 45.70); NIZORTAN 80 mg Tablet (80 mg, Tablet, SAR 59.20); Telfocus (80 mg, Tablet, SAR 47.35).

Is Telmisartan approved by the US FDA?

Drugs@FDA lists 19 application product lines for Telmisartan, including TELMISARTAN (Prescription); TELMISARTAN (Prescription); TELMISARTAN (Prescription); TELMISARTAN (Prescription); TELMISARTAN (Prescription).

Is Telmisartan authorised in the European Union?

EMA lists 5 centrally authorised medicines containing Telmisartan: Pritor, Micardis, Tolura, Telmisartan Actavis, Telmisartan Teva Pharma.

Are there safety signals or safety updates for Telmisartan?

EMA PRAC: 3 entries; US FDA: 3 entries (latest 2024-10-31).

Active substance

Telmisartan

SFDA 6
US FDA 19
EMA 8
Health Canada 26
US price lines 3
NHS prices 3
Safety 6

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
MICARDIS 40 MG TAB	40 mg	Tablet · Oral use	28 Blister	SAR 49.60	NCE · Prescription	BOEHRINGER INGELHEIM	Valid
MICARDIS 80 MG TAB	80 mg	Tablet · Oral use	28 Blister	SAR 65.95	NCE · Prescription	BOEHRINGER INGELHEIM	Valid
NIZORTAN 40 mg Tablet	40 mg	Tablet · Oral use	28 Blister	SAR 45.70	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
NIZORTAN 80 mg Tablet	80 mg	Tablet · Oral use	28 Blister	SAR 59.20	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Telfocus	80 mg	Tablet · Oral use	28 Blister	SAR 47.35	Generic · Prescription	Aurobindo Pharma Limited	Valid
Telfocus	40 mg	Tablet · Oral use	28 Blister	SAR 36.60	Generic · Prescription	Aurobindo Pharma Limited	Valid

Indications — CHI Daman Drug Formulary

CHRONIC KIDNEY DISEASE; CORONARY ARTERY DISEASE; HYPERTENSION; SICKLE CELL DISEASE - ALBUMINURIA MANAGEMENT; SYSTEMIC LUPUS ERYTHEMATOSUS

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

Product	Strength	Form · route	Applicant	Status	First approved
TELMISARTAN	20MG; 40MG; 80MG	tablet · oral	CHARTWELL RX	Prescription	8 Jan 2014
TELMISARTAN	20MG; 40MG; 80MG	tablet · oral	GLENMARK PHARMS LTD	Prescription	7 Jul 2014
TELMISARTAN	20MG; 40MG; 80MG	tablet · oral	ALEMBIC	Prescription	7 Jul 2014
TELMISARTAN	20MG; 40MG; 80MG	tablet · oral	MYLAN	Prescription	7 Jul 2014
TELMISARTAN	20MG; 40MG; 80MG	tablet · oral	TORRENT	Prescription	7 Jul 2014
TELMISARTAN	20MG; 40MG; 80MG	tablet · oral	ZYDUS PHARMS	Prescription	26 Aug 2014
TELMISARTAN	20MG; 40MG; 80MG	tablet · oral	SANDOZ	Prescription	3 Nov 2014
TELMISARTAN	20MG; 40MG; 80MG	tablet · oral	AUROBINDO PHARMA	Prescription	3 Sep 2015
TELMISARTAN	20MG; 40MG; 80MG	tablet · oral	AMNEAL PHARMS	Prescription	8 Sep 2015
TELMISARTAN	20MG; 40MG; 80MG	tablet · oral	ADAPTIS	Prescription	30 Oct 2015
TELMISARTAN	20MG; 40MG; 80MG	tablet · oral	JUBILANT GENERICS	Prescription	22 Aug 2016
TELMISARTAN	20MG; 40MG; 80MG	tablet · oral	PRINSTON INC	Prescription	3 May 2017
TELMISARTAN	20MG; 40MG; 80MG	tablet · oral	CADILA PHARMS LTD	Prescription	25 Jul 2017
TELMISARTAN	20MG; 40MG; 80MG	tablet · oral	MANKIND PHARMA	Prescription	15 Oct 2024
TELMISARTAN	20MG; 40MG; 80MG	tablet · oral	MACLEODS PHARMS	Prescription	15 Jan 2025
MICARDIS	40MG; 80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	BOEHRINGER INGELHEIM	Discontinued	10 Nov 1998
TELMISARTAN	20MG; 40MG; 80MG	tablet · oral	HETERO LABS LTD V	Discontinued	22 Apr 2016
TELMISARTAN	20MG; 40MG; 80MG	tablet · oral	MICRO LABS	Discontinued	3 Oct 2017
TELMISARTAN	20MG; 40MG; 80MG	tablet · oral	HISUN PHARM HANGZHOU	Discontinued	19 Feb 2019

EMA European Union — centrally authorised medicines

Pritor Bayer AG · Authorised · authorised 11 Dec 1998 · ATC C09CA07

Therapeutic indication (EMA)

Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or; type-2 diabetes mellitus with documented target-organ damage.

Micardis Boehringer Ingelheim International GmbH · Authorised · authorised 16 Dec 1998 · ATC C09CA07

Therapeutic indication (EMA)

Tolura Krka, d.d., Novo mesto · Authorised · authorised 4 Jun 2010 · ATC C09CA07

Therapeutic indication (EMA)

Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease or peripheral arterial disease) or; type 2 diabetes mellitus with documented target organ damage.

Telmisartan Actavis Actavis Group PTC ehf · Authorised · authorised 29 Sep 2010 · ATC C09CA07

Therapeutic indication (EMA)

Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or; type 2 diabetes mellitus with documented target organ damage.

Telmisartan Teva Pharma Teva B.V. · Authorised · authorised 3 Oct 2011 · ATC C09CA07

Therapeutic indication (EMA)

Treatment of essential hypertension in adults.

Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG) Bayer AG · Withdrawn · authorised 16 Dec 1998 · ATC C09CA07

Therapeutic indication (EMA)

Telmisartan Teva Teva B.V. · Withdrawn · authorised 25 Jan 2010 · ATC C09CA07

Therapeutic indication (EMA)

Treatment of essential hypertension in adults

Onduarp Boehringer Ingelheim International GmbH · Withdrawn · authorised 24 Nov 2011 · ATC C09DB04

Therapeutic indication (EMA)

Treatment of essential hypertension in adults: Add on therapy Onduarp is indicated in adults whose blood pressure is not adequately controlled on amlodipine. Replacement therapy Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Onduarp containing the same component doses.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACH-TELMISARTAN	02407485	40 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
ACH-TELMISARTAN	02407493	80 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
AG-TELMISARTAN	02484536	40 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-TELMISARTAN	02484544	80 MG	TABLET · ORAL	ANGITA PHARMA INC.
AURO-TELMISARTAN	02453568	40 MG	TABLET · ORAL	AURO PHARMA INC
AURO-TELMISARTAN	02453576	80 MG	TABLET · ORAL	AURO PHARMA INC
JAMP TELMISARTAN	02386755	40 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP TELMISARTAN	02386763	80 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
MICARDIS 40MG TAB	02240769	40 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE
MICARDIS 80MG TAB	02240770	80 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE
MINT-TELMISARTAN	02486369	40 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-TELMISARTAN	02486377	80 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
NRA-TELMISARTAN	02503794	40 MG	TABLET · ORAL	NORA PHARMA INC
NRA-TELMISARTAN	02503808	80 MG	TABLET · ORAL	NORA PHARMA INC
PMS-TELMISARTAN	02499622	40 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-TELMISARTAN	02499630	80 MG	TABLET · ORAL	PHARMASCIENCE INC
SANDOZ TELMISARTAN	02375958	40 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ TELMISARTAN	02375966	80 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
TELMISARTAN	02388944	40 MG	TABLET · ORAL	SANIS HEALTH INC
TELMISARTAN	02388952	80 MG	TABLET · ORAL	SANIS HEALTH INC
TELMISARTAN	02390345	40 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
TELMISARTAN	02390353	80 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
TELMISARTAN	02395223	40 MG	TABLET · ORAL	PRO DOC LIMITEE
TELMISARTAN	02395231	80 MG	TABLET · ORAL	PRO DOC LIMITEE
TEVA-TELMISARTAN	02320177	40 MG	TABLET · ORAL	TEVA CANADA LIMITED

1 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TELMISARTAN 20 MG TABLET	$0.10581	per EA	7 Oct 2026
US NADAC	TELMISARTAN 40 MG TABLET	$0.15031	per EA	7 Oct 2026
US NADAC	TELMISARTAN 80 MG TABLET	$0.16325	per EA	7 Oct 2026
NHS Drug Tariff	Telmisartan 20mg tablets	£1.60	28 tablet	1 Oct 2026
NHS Drug Tariff	Telmisartan 40mg tablets	£1.57	28 tablet	1 Oct 2026
NHS Drug Tariff	Telmisartan 80mg tablets	£1.81	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
EMA PRAC 11 Jul 2024 PRAC signal: Intestinal angioedema
Action for MAH: update of the product information: No
US FDA 19 Dec 2022 MICARDIS — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 19 Dec 2022 MICARDIS HCT — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 1 Feb 2018 TWYNSTA — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 9 Jun 2017 PRAC signal: Risk of psoriasis or exacerbation of psoriasis
Action for MAH: update of the product information: No

All safety entries for telmisartan →

Combinations containing Telmisartan

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.