Germany· DE-A57-edd1275f834597e1
Heitrin
A medicinal product containing terazosin hydrochloride dihydrate, registered in Germany by Amdipharm Limited.
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
- Terazosin Hydrochloride Dihydrate
- Manufacturer
- Amdipharm Limited
- 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
Terazosin hydrochloride dihydrate in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesterazosinBryant Ranch Prepack
- United KingdomBenph 2mg tabletsViatris UK Healthcare Ltd
- ItalyITRINEBERLIFE FARMACEUTICI S.P.A.
- BelgiumHytrin 1 mgAmdipharm
- SpainALFAPROST 5 mg COMPRIMIDOSBiowise Pharmaceuticals, S.L.
- CanadaAPO-TERAZOSINAPOTEX INC
- NetherlandsHytrin 10, tabletten 10 mgAmdipharm Limited
- FranceDYSALFA 1 mg, compriméAMDIPHARM
Authorised across Europe · EMA
The same active substance is authorised in 19 EEA countries. Names it is sold under:
- Austria · Uroflo, Vicard
- Belgium · Hytrin, Terazosab
- Czechia · Kornam
- Denmark · Sinalfa
- Spain · Alfaprost, Mayul
- France · Dysalfa, Hytrine
- United Kingdom (Northern Ireland) · Hytrin, Terazosin
- Greece · Hytrin
- Hungary · Setegis
- Ireland · Hytrin
- Italy · Itrin, Prostatil
- Luxembourg · Hytrin, Terazosab
- Netherlands · Hytrin, Terazosine Accord
- Norway · Sinalfa
- Poland · Hytrin, Kornam
- Portugal · Hytrin
- Sweden · Sinalfa
- Slovenia · Kornam
- Slovakia · Kornam
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/db3a048a-0b5d-4ab9-82ff-ce7b3e86e0c3 GET /v1/drugs/db3a048a-0b5d-4ab9-82ff-ce7b3e86e0c3?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": "Terazosin Hydrochloride Dihydrate",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about terazosin hydrochloride dihydrate.
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.