Is Amlodipine + 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 Amlodipine + Telmisartan, including COVATEL (80,5 mg,mg, Tablet, SAR 59.20); COVATEL (80,10 mg,mg, Tablet, SAR 59.20); COVATEL (40,5 mg,mg, Tablet, SAR 45.70); COVATEL 40MG/10MG TABLET (40,10 mg,mg, Tablet, SAR 45.70); TWYNSTA (80,5 mg,mg, Tablet, SAR 72.85).

Is Amlodipine + Telmisartan approved by the US FDA?

Drugs@FDA lists 5 application product lines for Amlodipine + Telmisartan, including TELMISARTAN AND AMLODIPINE (Prescription); TWYNSTA (Discontinued); TELMISARTAN AND AMLODIPINE (Discontinued); TELMISARTAN AND AMLODIPINE (Discontinued); TELMISARTAN AND AMLODIPINE (Discontinued).

Is Amlodipine + Telmisartan authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Amlodipine + Telmisartan: Twynsta.

Is Amlodipine + Telmisartan on the WHO Model List of Essential Medicines?

Yes — 12.3. Antihypertensive medicines (core list): Essential hypertension.

Active substances

Amlodipine + Telmisartan

SFDA 6
US FDA 5
EMA 1
Health Canada 8
US price lines 4
WHO EML 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
COVATEL	80,5 mg,mg	Tablet · Oral use	28 Blister	SAR 59.20	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
COVATEL	80,10 mg,mg	Tablet · Oral use	28 Blister	SAR 59.20	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
COVATEL	40,5 mg,mg	Tablet · Oral use	28 Blister	SAR 45.70	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
COVATEL 40MG/10MG TABLET	40,10 mg,mg	Tablet · Oral use	28 Blister	SAR 45.70	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
TWYNSTA	80,5 mg,mg	Tablet · Oral use	28 Blister	SAR 72.85	Generic · Prescription	BOEHRINGER INGELHEIM	Valid
TWYNSTA	80,10 mg,mg	Tablet · Oral use	28 Blister	SAR 72.85	Generic · Prescription	BOEHRINGER INGELHEIM	Valid

Indications — CHI Daman Drug Formulary

HYPERTENSION

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

Product	Strength	Form · route	Applicant	Status	First approved
TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG; EQ 10MG BASE;40MG; EQ 5MG BASE;80MG; EQ 10MG BASE;80MG	tablet · oral	MYLAN	Prescription	26 Aug 2014
TWYNSTA	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	BOEHRINGER INGELHEIM	Discontinued	16 Oct 2009
TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG; EQ 10MG BASE;40MG; EQ 5MG BASE;80MG; EQ 10MG BASE;80MG	tablet · oral	LUPIN	Discontinued	8 Jan 2014
TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG; EQ 10MG BASE;40MG; EQ 5MG BASE;80MG; EQ 10MG BASE;80MG	tablet · oral	TORRENT	Discontinued	8 Jan 2014
TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG; EQ 10MG BASE;40MG; EQ 5MG BASE;80MG; EQ 10MG BASE;80MG	tablet · oral	ALEMBIC	Discontinued	17 Nov 2016

EMA European Union — centrally authorised medicines

Twynsta Boehringer Ingelheim International GmbH · Authorised · authorised 7 Oct 2010 · ATC C09DB04

Therapeutic indication (EMA)

Treatment of essential hypertension in adults: Add-on therapy Twynsta 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 Twynsta containing the same component doses.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
RIVA-TELMISARTAN/AMLODIPINE	02559854	40 MG; 5 MG	TABLET · ORAL	LABORATOIRE RIVA INC.
RIVA-TELMISARTAN/AMLODIPINE	02559862	40 MG; 10 MG	TABLET · ORAL	LABORATOIRE RIVA INC.
RIVA-TELMISARTAN/AMLODIPINE	02559870	80 MG; 5 MG	TABLET · ORAL	LABORATOIRE RIVA INC.
RIVA-TELMISARTAN/AMLODIPINE	02559889	80 MG; 10 MG	TABLET · ORAL	LABORATOIRE RIVA INC.
TWYNSTA	02371022	5 MG; 40 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE
TWYNSTA	02371030	10 MG; 40 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE
TWYNSTA	02371049	5 MG; 80 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE
TWYNSTA	02371057	10 MG; 80 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TELMISARTAN-AMLODIPINE 40-10	$2.87974	per EA	23 Sep 2026
US NADAC	TELMISARTAN-AMLODIPINE 40-5 MG	$3.19076	per EA	23 Sep 2026
US NADAC	TELMISARTAN-AMLODIPINE 80-10	$2.93583	per EA	23 Sep 2026
US NADAC	TELMISARTAN-AMLODIPINE 80-5 MG	$2.87025	per EA	23 Sep 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.

WHO WHO Model List of Essential Medicines (2025)

12.3. Antihypertensive medicines · core
Essential hypertension
Oral > Solid: 40 mg + 5 mg; 80 mg + 5 mg; 80 mg + 10 mg

Components

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.