Germany· DE-A57-3fbcb7518e437002
Amlodipin/Valsartan/Hct Holsten
A medicinal product containing valsartan, amlodipine, hydrochlorothiazide, registered in Germany by Holsten Pharma Gmbh.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Valsartan, Amlodipine, Hydrochlorothiazide
- Manufacturer
- Holsten Pharma Gmbh
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Valsartan, amlodipine, hydrochlorothiazide 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 26 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
- 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 EMA Article 57 (European Union). 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/97f7ff76-dd97-42a5-abea-4130487e6a36 GET /v1/drugs/97f7ff76-dd97-42a5-abea-4130487e6a36?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.
{
"pzn": null,
"route": "Oral Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Valsartan, Amlodipine, Hydrochlorothiazide",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about valsartan, amlodipine, hydrochlorothiazide.
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.