Regulatory PathRegulatory requirements compared

Active substances

Hydrochlorothiazide + Telmisartan

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Ozevlor Plus80,25 mg,mgTablet · Oral use30 BlisterSAR 54.25Generic · PrescriptionSAUDI PHARMACEUTICAL INDUSTRIESValid
Ozevlor Plus80,12.50 mg,mgTablet · Oral use30 BlisterSAR 54.25Generic · PrescriptionSAUDI PHARMACEUTICAL INDUSTRIESValid
Ozevlor Plus40,12.50 mg,mgTablet · Oral use30 BlisterSAR 54.25Generic · PrescriptionSAUDI PHARMACEUTICAL INDUSTRIESValid
MICARDIS PLUS40,12.5 mg,mgTablet · Oral use28 BlisterSAR 65.05NCE · PrescriptionBOEHRINGER INGELHEIMWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

HYPERTENSION

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

ProductStrengthForm · routeApplicantStatusFirst approved
MICARDIS HCT12.5MG;40MG; 12.5MG;80MG; 25MG;80MGtablet · oralBOEHRINGER INGELHEIMPrescription17 Nov 2000
TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MG; 12.5MG;80MG; 25MG;80MGtablet · oralALEMBICPrescription25 Feb 2014
TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MG; 12.5MG;80MG; 25MG;80MGtablet · oralAUROBINDO PHARMAPrescription15 Dec 2016
TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MG; 12.5MG;80MG; 25MG;80MGtablet · oralZYDUS PHARMSPrescription15 Aug 2017
TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MG; 12.5MG;80MG; 25MG;80MGtablet · oralPRINSTON INCPrescription6 Nov 2017
TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MG; 12.5MG;80MG; 25MG;80MGtablet · oralGLENMARK PHARMS LTDPrescription4 Mar 2019
TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MG; 12.5MG;80MG; 25MG;80MGtablet · oralNATCODiscontinued25 Feb 2014
TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MG; 12.5MG;80MG; 25MG;80MGtablet · oralTORRENTDiscontinued25 Feb 2014
TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MG; 12.5MG;80MG; 25MG;80MGtablet · oralLUPINDiscontinued7 Aug 2014
TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MG; 12.5MG;80MG; 25MG;80MGtablet · oralMACLEODS PHARMSDiscontinued2 Nov 2015
TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MG; 12.5MG;80MG; 25MG;80MGtablet · oralMANKIND PHARMADiscontinued3 Mar 2025

EMA European Union — centrally authorised medicines

MicardisPlus Boehringer Ingelheim International GmbH · Authorised · authorised 19 Apr 2002 · ATC C09DA07

Therapeutic indication (EMA)

Treatment of essential hypertension. MicardisPlus fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone. MicardisPlus fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on MicardisPlus (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.

Tolucombi Krka, d.d., Novo mesto · Authorised · authorised 13 Mar 2013 · ATC C09DA07

Therapeutic indication (EMA)

Tolucombi fixed-dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Tolucombi 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.

Actelsar HCT Actavis Group PTC ehf · Authorised · authorised 13 Mar 2013 · ATC C09DA07

Therapeutic indication (EMA)

Treatment of essential hypertension. Actelsar HCT fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone. Actelsar HCT fixed-dose combination (80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone. Actelsar HCT fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Actelsar HCT 80 mg / 12.5 mg (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.

Kinzalkomb Bayer AG · Withdrawn · authorised 19 Apr 2002 · ATC C09DA07

Therapeutic indication (EMA)

Treatment of essential hypertension. Kinzalkomb fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone. Kinzalkomb fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on Kinzalkomb (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.

PritorPlus Bayer AG · Withdrawn · authorised 22 Apr 2002 · ATC C09DA07

Therapeutic indication (EMA)

Treatment of essential hypertension. PritorPlus fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide, 80mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on telmisartan alone. PritorPlus fixed-dose combination (80 mg telmisartan / 25 mg hydrochlorothiazide) is indicated in patients whose blood pressure is not adequately controlled on PritorPlus (80 mg telmisartan / 12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ACH-TELMISARTAN HCTZ0241911412.5 MG; 80 MGTABLET · ORALACCORD HEALTHCARE INC
ACH-TELMISARTAN HCTZ0241912225 MG; 80 MGTABLET · ORALACCORD HEALTHCARE INC
AG TELMISARTAN-HCT0248456080 MG; 12.5 MGTABLET · ORALANGITA PHARMA INC.
AG TELMISARTAN-HCT0248457925 MG; 80 MGTABLET · ORALANGITA PHARMA INC.
AURO-TELMISARTAN HCTZ0245638980 MG; 12.5 MGTABLET · ORALAURO PHARMA INC
AURO-TELMISARTAN HCTZ0245639725 MG; 80 MGTABLET · ORALAURO PHARMA INC
JAMP TELMISARTAN-HCT0238994012.5 MG; 80 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP TELMISARTAN-HCT0238995980 MG; 25 MGTABLET · ORALJAMP PHARMA CORPORATION
MICARDIS PLUS0224434412.5 MG; 80 MGTABLET · ORALBOEHRINGER INGELHEIM (CANADA) LTD LTEE
MICARDIS PLUS0231870980 MG; 25 MGTABLET · ORALBOEHRINGER INGELHEIM (CANADA) LTD LTEE
NRA-TELMISARTAN/HCTZ0250413880 MG; 25 MGTABLET · ORALNORA PHARMA INC
NRA-TELMISARTAN/HCTZ0250414612.5 MG; 80 MGTABLET · ORALNORA PHARMA INC
PRO-TELMISARTAN-HCTZ0239552512.5 MG; 80 MGTABLET · ORALPRO DOC LIMITEE
PRO-TELMISARTAN-HCTZ0239553380 MG; 25 MGTABLET · ORALPRO DOC LIMITEE
SANDOZ TELMISARTAN HCT0239355712.5 MG; 80 MGTABLET · ORALSANDOZ CANADA INCORPORATED
SANDOZ TELMISARTAN HCT0239356525 MG; 80 MGTABLET · ORALSANDOZ CANADA INCORPORATED
TELMISARTAN HCTZ0239030280 MG; 12.5 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
TELMISARTAN HCTZ0239031025 MG; 80 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
TELMISARTAN/HCTZ0239535580 MG; 12.5 MGTABLET · ORALSANIS HEALTH INC
TELMISARTAN/HCTZ0239536380 MG; 25 MGTABLET · ORALSANIS HEALTH INC
TEVA-TELMISARTAN HCTZ0233028880 MG; 12.5 MGTABLET · ORALTEVA CANADA LIMITED
TEVA-TELMISARTAN HCTZ0237925225.0 MG; 80.0 MGTABLET · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACMICARDIS HCT 40-12.5 MG TABLET$4.48356per EA23 Sep 2026
US NADACMICARDIS HCT 80-12.5 MG TABLET$4.472per EA23 Sep 2026
US NADACMICARDIS HCT 80-25 MG TABLET$4.4768per EA21 Jan 2026
US NADACTELMISARTAN-HYDROCHLOROTHIAZIDE 40-12.5 MG TB$0.3567per EA23 Sep 2026
US NADACTELMISARTAN-HYDROCHLOROTHIAZIDE 80-12.5 MG TB$0.31445per EA23 Sep 2026
US NADACTELMISARTAN-HYDROCHLOROTHIAZIDE 80-25 MG TAB$0.33828per EA23 Sep 2026
NHS Drug TariffTelmisartan 40mg / Hydrochlorothiazide 12.5mg tablets£2.6328 tablet1 Oct 2026
NHS Drug TariffTelmisartan 80mg / Hydrochlorothiazide 12.5mg tablets£4.2228 tablet1 Oct 2026
NHS Drug TariffTelmisartan 80mg / Hydrochlorothiazide 25mg tablets£17.0028 tablet1 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.

WHO WHO Model List of Essential Medicines (2025)

  • 12.3. Antihypertensive medicines · core
    Essential hypertension
    Oral > Solid: 40 mg + 12.5 mg; 80 mg + 12.5 mg; 80 mg + 25 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.