Spain· ES:84776
AMBRISENTAN ALEMBIC 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
A medicinal product containing ambrisentán, registered in Spain by Alembic Pharmaceuticals Europe Limited.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- ambrisentán
- Manufacturer
- Alembic Pharmaceuticals Europe Limited
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- June 3, 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
Ambrisentán in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaAMBRISENTAN ACCORDACCORD HEALTHCARE POLSKA Sp. z o.o., Varšava
- United StatesambrisentanA-S Medication Solutions
- NetherlandsAmbrisentan Accord 5 mg, filmomhulde tablettenAccord Healthcare B.V.
- FinlandAmbrisentan AccordAccord Healthcare B.V.
- FranceAMBRISENTAN ACCORD 5 mg, comprimé pelliculéACCORD HEALTHCARE FRANCE
- SwedenAmbrisentan Accord 5 mg Filmdragerad tablettAccord Healthcare B.V.
- ItalyAMBRISENTAN ACCORDACCORD HEALTHCARE SLU
- BelgiumAmbrisentan AB 5 mgAurobindo
Authorised across Europe · EMA
The same active substance is authorised in 26 EEA countries. Names it is sold under:
- Austria · Ambrisentan Accord, Ambrisentan Aop
- Belgium · Ambrisentan Accord, Ambrisentan Sandoz
- Bulgaria · Aмбрисентан Aкорд, Амбрисентан Зентива
- Cyprus · Ambrisentan Msn, Ambrisentan Sapiens
- Czechia · Ambrisentan Accord, Ambrisentan Sandoz
- Germany · Ambripuren, Ambrisentan
- Denmark · Ambrisentan "sandoz", Ambrisentan Accord
- Estonia · Ambrisentan Inteli, Ambrisentan Norameda
- Finland · Ambrisentan Accord
- France · Ambrisentan Accord, Ambrisentan Arrow
- United Kingdom (Northern Ireland) · Ambrisentan Accord, Ambrisentan Axunio
- Greece · Ambicipen, Ambrisentan Accord
- Croatia · Ambrisentan Accord
- Hungary · Ambrisentan Azr
- Ireland · Ambrisentan Accord
- Iceland · Ambrisentan Viatris, Volibris
- Italy · Ambrisentan Accord, Ambrisentan Medac
- Liechtenstein · Ambrisentan Viatris, Volibris
- Lithuania · Ambrisentan Aop, Ambrisentan Inteli
- Latvia · Ambrisentan Inteli, Ambrisentan Norameda
- Netherlands · Ambrisentan Accord, Ambrisentan Aop
- Norway · Ambrisentan Accord, Ambrisentan Viatris
- Portugal · Ambrisentano Accord, Ambrisentano Generis
- Sweden · Ambrisentan Accord, Ambrisentan Bluefish
- Slovenia · Ambrisentan Accord
- Slovakia · Ambrisentan Aop
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 AEMPS CIMA (Spain). 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/c58212c1-aa3f-4523-a507-640a4f2786e3 GET /v1/drugs/c58212c1-aa3f-4523-a507-640a4f2786e3?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.
{
"cpresc": "Uso Hospitalario",
"estado": "{\"aut\":1578501158000,\"rev\":1773737718000}",
"nregistro": "84776",
"substance": "ambrisentán"
}See everything about ambrisentán.
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.