Spain· ES:61658
MIZOLEN 10 mg COMPRIMIDOS DE LIBERACION MODIFICADA
A medicinal product containing mizolastina, registered in Spain by Opella Healthcare Spain S.L..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- mizolastina
- Manufacturer
- Opella Healthcare Spain S.L.
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 2026
Packs & prices · 1
1 priced- cima_codigo66535620EUR 9.74
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Mizolastina in 7 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandMistamineGalderma Nordic AB
- United KingdomMistamine 10mg modified-release tabletsGalderma (UK) Ltd
- BelgiumMizollen 10 mgOpella Healthcare Belgium
- NetherlandsMizollen 10 mg, tabletten met gereguleerde afgifteOpella Healthcare France S.A.S.
- FranceMIZOCLER 10 mg, comprimé pelliculé à libération modifiéeDESMA PHARMA
- ItalyZOLISTAM*20 cpr 10 mg rilascio modificatoOPELLA HEALTHCARE ITALY Srl
- GermanyMizollenA. Nattermann & Cie. Gmbh
Authorised across Europe · EMA
The same active substance is authorised in 5 EEA countries. Names it is sold under:
- Germany · Mizollen
- France · Mizocler, Mizollen
- Greece · Oriens
- Italy · Mizollen, Zolistam
- Netherlands · Mizollen
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/a96b1f9c-8584-4821-9ea5-f5e8740512a3 GET /v1/drugs/a96b1f9c-8584-4821-9ea5-f5e8740512a3?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\":888706800000,\"rev\":1763720347000}",
"nregistro": "61658",
"substance": "mizolastina"
}See everything about mizolastina.
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.