Spain· ES:58549
DATOLAN 7,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA
A medicinal product containing zopiclona, registered in Spain by Faes Farma S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- zopiclona
- Manufacturer
- Faes Farma 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
Zopiclona in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- PolandApoDreamAurovitas Pharma Polska Sp. z o.o.
- CzechiaZOPICLONE GRINDEKSAS GRINDEKS, Riga
- FranceIMOVANE 7,5 mg, comprimé pelliculé sécableSANOFI WINTHROP INDUSTRIE
- BelgiumImovane 7,5 mgImpexeco
- SwedenZopiclon Stada 7,5 mg Filmdragerad tablettSTADA Arzneimittel AG
- NetherlandsZopiclon 7,5 mg, filmomhulde tablettenSynthon B.V.
- FinlandImovaneSanofi Oy
- IrelandZimoclone 7.5 mg film-coated tabletsViatris Limited
Authorised across Europe · EMA
The same active substance is authorised in 27 EEA countries. Names it is sold under:
- Austria · Somnal Stada Arzneimittel, Zopiclon Grindeks
- Belgium · Imovane, Zopiclone Ab
- Bulgaria · Екодорм, Зопиклон Гриндекс
- Czechia · Zopiclone Grindeks, Zopiclone Olpha
- Germany · Ximovan, Zopiclodura
- Denmark · Imozop, Somnols
- Estonia · Imovane, Somnols
- Finland · Imovane, Zopiclone Grindeks
- France · Imovane, Zopiclone Almus
- United Kingdom (Northern Ireland) · Zimovane, Zopiclone
- Greece · Imovane
- Croatia · Zonotte, Zopiklon Grindeks
- Hungary · Imovane, Somnol
- Ireland · Zimoclone, Zimovane
- Iceland · Imomed, Imovane
- Italy · Imovane, Zopiclone Aristo
- Lithuania · Somnols, Zopiclone Eletis
- Luxembourg · Imovane, Zopiclone Eg
- Latvia · Imovane, Somnols
- Netherlands · Zopiclon Cf, Zopiclon Grindeks
- Norway · Imovane, Sonlax
- Poland · Apodream, Dobroson
- Portugal · Zopiclona Grindeks
- Romania · Imovane, Sonlax
- Sweden · Imovane, Zopiclon Stada
- Slovenia · Maknotte, Zopiklon Grindeks
- Slovakia · Somnols, Sonlax
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/a4252d16-707a-47d3-8482-250f147586c5 GET /v1/drugs/a4252d16-707a-47d3-8482-250f147586c5?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\":670456800000,\"rev\":1716807366000}",
"nregistro": "58549",
"substance": "zopiclona"
}See everything about zopiclona.
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.