Spain· ES:20080197
BALZAK 40MG/5MG COMPRIMIDOS RECUBIERTOS CON PELICULA
A medicinal product containing olmesartán + amlodipino, registered in Spain by Menarini International Operations Luxembourg S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- olmesartán + amlodipino
- Manufacturer
- Menarini International Operations Luxembourg S.A.
- 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
Olmesartán + amlodipino in 5 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandOlmesartan Amlo Spirig HC 20mg/5mg, FilmtablettenSpirig HealthCare AG
- NetherlandsBelfor 20 mg/5 mg, filmomhulde tablettenMenarini International Operations Luxembourg S.A.
- PolandElestarMenarini International Operations Luxembourg S.A.
- United KingdomSevikar 20mg/5mg tabletsCST Pharma Ltd
- GermanyOlmesartan/Amlodipin AlAliud Pharma Gmbh
Authorised across Europe · EMA
The same active substance is authorised in 7 EEA countries. Names it is sold under:
- Belgium · Olmesartan/Amlodipine Eg
- Bulgaria · Олмезид Am
- Germany · Olmesartan/Amlodipin Al
- Ireland · Olmesartan/Amlodipine Clonmel
- Italy · Olmesartan E Amlodipina Eg
- Luxembourg · Olmesartan/Amlodipine Eg
- Netherlands · Olmesartanmedoxomil/Amlodipine Stada
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/b6013e8e-455c-480e-b8da-5b507ee44452 GET /v1/drugs/b6013e8e-455c-480e-b8da-5b507ee44452?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": "Medicamento Sujeto A Prescripción Médica",
"estado": "{\"aut\":1731684070000}",
"nregistro": "20080197",
"substance": "olmesartán + amlodipino"
}See everything about olmesartán + amlodipino.
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.