Spain· ES:65965
MIRTAZAPINA SANDOZ FARMACEUTICA 45 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
A medicinal product containing mirtazapina, registered in Spain by Sandoz Farmaceutica S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- mirtazapina
- Manufacturer
- Sandoz Farmaceutica S.A.
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- August 12, 2026
Packs & prices · 1
1 priced- cima_codigo83948030EUR 25.57
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Mirtazapina in 17 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandAlphamirtWoerwag Pharma GmbH & CoKG
- United StatesmirtazapineXLCare Pharmaceuticals Inc.
- SwitzerlandMirtazapin Sandoz 45, FilmtablettenSandoz Pharmaceuticals AG
- NetherlandsMirtazapine Amarox 45 mg filmomhulde tablettenAmarox Pharma B.V.
- CzechiaMIRANOX+pharma arzneimittel gmbh, Graz
- SwedenMirtazapin Actavis 45 mg Filmdragerad tablettActavis Group PTC ehf.
- PolandMirtazapine BluefishBluefish Pharmaceuticals AB
- BelgiumMirtazapin AB 45 mgAurobindo Pharma
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · Mirtabene, Mirtabene Ratiopharm Gmbh
- Belgium · Mirtazapine Ab, Mirtazapine Eg
- Bulgaria · Мирзатен, Мирзатен Q-Tab
- Cyprus · Mirtazapin Aurobindo, Remeron
- Czechia · Miranox, Mirtazapin +pharma
- Germany · Mirta, Mirta Tad
- Denmark · Combar, Mirtazapin "hexal"
- Estonia · Mirtastad, Mirtazapin Actavis
- Finland · Mirtazapin Actavis, Mirtazapin Grindeks
- France · Mirtazapine Almus, Mirtazapine Arrow
- United Kingdom (Northern Ireland) · Mirtazapine, Mirtazapine Accord Healthcare
- Greece · Anchopriv, Azapin
- Croatia · Calixta, Mirtazapin Genericon
- Hungary · Mirtadepi, Mirtastad
- Ireland · Mirap, Mirap Distab
- Iceland · Míron, Miron Smelt
- Italy · Mirtazapin Grindeks, Mirtazapina Almus
- Lithuania · Mirtazapin Actavis, Mirtazapin Grindeks
- Luxembourg · Mirtazapin Ratiopharm, Mirtazapine Eg
- Latvia · Mirtastad, Mirtazapine Grindeks
- Malta · Mirap, Mirap Distab
- Netherlands · Mirtazapine Amarox, Mirtazapine Aurobindo
- Norway · Mirtazapin Actavis, Mirtazapin Bluefish
- Poland · Auromirta Oro, Mirtagen
- Portugal · Mirtazapin Grindeks, Mirtazapina Almus
- Romania · Mirtazapin Arena, Mirtazapină Aurobindo
- Sweden · Mirtazapin Actavis, Mirtazapin Alternova
- Slovenia · Mirtazapin Grindeks, Mirtazapine Grindeks
- Slovakia · Mirzaten, Mirzaten Q-Tab
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/cb316798-df6a-4bc3-9c9b-c996bc76e28d GET /v1/drugs/cb316798-df6a-4bc3-9c9b-c996bc76e28d?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\":1081980000000,\"susp\":1777982712000}",
"nregistro": "65965",
"substance": "mirtazapina"
}See everything about mirtazapina.
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.