France· FR:65369123
EXFORGE HCT 5 mg/160 mg/12,5 mg, comprimé pelliculé
A medicinal product containing hydrochlorothiazide + valsartan + bésilate d'amlodipine, registered in France by NOVARTIS EUROPHARM (IRLANDE).
Checked against Base de données publique des médicaments — BDPM (France) on
Informational only — not a medical device.
The record
At a glance
Base de données publique des médicaments — BDPM (France)- Active substance
- HYDROCHLOROTHIAZIDE + VALSARTAN + BÉSILATE D'AMLODIPINE
- Manufacturer
- NOVARTIS EUROPHARM (IRLANDE)
- Country
- France (FR)
- ATC code
- —
- Reimbursed
- No
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 1
- cip133400939732756plaquette(s) PVC PVDC de 30 comprimé(s)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Hydrochlorothiazide + valsartan + bésilate d'amlodipine in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaCOPALIA HCTNovartis Europharm Limited, Dublin
- SpainAMLODIPINO/VALSARTAN/HIDROCLOROTIAZIDA CINFA 10 MG/160 MG/12,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGLaboratorios Cinfa S.A.
- FinlandAmlodipin/Valsartan/Hydrochlorothiazide OrionOrion Corporation
- SwitzerlandAmlodipin Valsartan HCT Sandoz
- PolandAmlodipine + Valsartan + Hydrochlorothiazide PolpharmaZakłady Farmaceutyczne POLPHARMA S.A.
- United StatesAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.
- IrelandAmlodipine/Valsartan/Hydrochlorothiazide Clonmel 10 mg/160 mg/12.5 mg film-coated tabletsClonmel Healthcare Ltd
- SwedenAmlodipin/Valsartan/Hydroklortiazid Teva 10 mg/320 mg/25 mg Filmdragerad tablettTeva Sweden AB
Authorised across Europe · EMA
The same active substance is authorised in 27 EEA countries. Names it is sold under:
- Austria · Amlodipin/Valsartan/Hct 1a Pharma, Amlodipin/Valsartan/Hct Sandoz
- Belgium · Amlodipine/Valsartan/Hydrochlorothiazide Krka
- Bulgaria · Aверкано, Аверкано
- Cyprus · Amlodipine/Valsartan/Hydrochlorothiazide Elpen, Amlodipine+valsartan+hydrochlorothiazide Genepharm
- Czechia · Valtricom
- Germany · Amlodipin Plus Valsartan Hct Hexal, Amlodipin/Valsartan/Hct
- Denmark · Amlodipin/Valsartan/Hydrochlorthiazid Elpen, Amlodipine/Valsartan/Hydrochlorothiazide Krka
- Estonia · Valtricom
- Spain · Amlodipino/Valsartán/Hidroclorotiazida Cinfa, Amlodipino/Valsartán/Hidroclorotiazida Combix
- Finland · Amlodipin/Valsartan/Hydrochlorothiazide Orion, Amlodipine/Valsartan/Hydrochlorothiazide Krka
- Greece · Amlodipine+valsartan+hydrochlorothiazide Genepharm, Amlodipine+valsartan+hydrochlorothiazide Tad
- Croatia · Amlodipin/Valsartan/Hidroklorotiazid Genepharm, Awerkano
- Hungary · Amlodipin/Valsartan/Hct Sandoz, Valtricom
- Ireland · Amlodipine/Valsartan/Hydrochlorothiazide Clonmel, Amlodipine/Valsartan/Hydrochlorothiazide Krka
- Iceland · Copalia Hct, Dafiro Hct
- Italy · Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma, Dipperam Hct
- Liechtenstein · Copalia Hct, Dafiro Hct
- Lithuania · Valtricom
- Latvia · Valtricom
- Netherlands · Amlodipin/Valsartan/Hct Stada, Amlodipine/Valsartan/Hct Sandoz
- Norway · Amlodipine/Valsartan/Hydrochlorothiazide Krka, Amlodipine/Valsartan/Hydrochlorothiazide Viatris
- Poland · Dipperam Hct, Valtricom
- Portugal · Amlodipina + Valsartan + Hidroclorotiazida Krka, Amlodipina + Valsartan + Hidroclorotiazida Macleods
- Romania · Valtricom
- Sweden · Amlodipin/Valsartan/Hydroklortiazid Teva, Trivals
- Slovenia · Awerkano, Valtricom
- Slovakia · Valtricom
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of Base de données publique des médicaments — BDPM (France). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/df4cb72d-12da-453c-b610-90b827dfb2b3 GET /v1/drugs/df4cb72d-12da-453c-b610-90b827dfb2b3?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"cis": "65369123",
"date_amm": "2009-10-16",
"type_amm": "Procédure centralisée",
"numero_ue": "EU/1/09/569",
"substance": "HYDROCHLOROTHIAZIDE + VALSARTAN + BÉSILATE D'AMLODIPINE",
"statut_amm": "Autorisation active",
"statut_bdm": "Warning disponibilité",
"forme_pharmaceutique": "comprimé pelliculé",
"voies_administration": "orale",
"etat_commercialisation": "Non commercialisée",
"surveillance_renforcee": "Non"
}See everything about hydrochlorothiazide + valsartan + bésilate d'amlodipine.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.