Spain· ES:58078
UNIKET RETARD 50 mg COMPRIMIDOS DE LIBERACION PROLONGADA
A medicinal product containing mononitrato de isosorbida, registered in Spain by Lacer S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- mononitrato de isosorbida
- Manufacturer
- Lacer S.A.
- 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_codigo86288830EUR 4.15
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Mononitrato de isosorbida in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomIsotard 50XL tabletsEvolan Pharma AB
- NorwayMonoket retardMerus Labs Luxco II S.à r.l.
- PolandEffox long 50Merus Labs Luxco II S.a R.L.
- United Statesisosorbide mononitrateCoupler LLC
- ItalyDURONITRINTOPRIDGE PHARMA (IRELAND) LTD
- FinlandFem-Mono RetardGenerics (UK) Limited
- CzechiaMONO MACK DEPOTPfizer Europe MA EEIG, Bruxelles
- GermanyElantan LongYinglian Health Pharmaceutical Gmbh
Authorised across Europe · EMA
The same active substance is authorised in 26 EEA countries. Names it is sold under:
- Austria · Ismn Genericon, Monoket Retard
- Bulgaria · Oликард, Изосорб
- Cyprus · Imdur, Monorem
- Czechia · Mono Mack Depot, Monosan
- Germany · Elantan Long, Is 5 Mono
- Denmark · Farmidur, Fem-Mono Retard
- Estonia · Imdur, Isomonit
- Finland · Imdur, Isangina
- United Kingdom (Northern Ireland) · Angitate, Carmil Xl
- Greece · Dilavase, G-Dil
- Croatia · Ismn Genericon, Isocard
- Hungary · Mono Mack Depot, Olicard
- Ireland · Elantan, Elantan La
- Iceland · Fem-Mono Retard, Imdur
- Italy · Duronitrin, Elan
- Lithuania · Imdur, Ismn Stada
- Latvia · Imdur, Ismn Stada
- Malta · Imdur, Monorem R
- Netherlands · Isosorbide Mononitraat Retard Rph, Isosorbide Mononitraat Retard Viatris
- Norway · Imdur, Isomex
- Poland · Effox Long, Mononit
- Portugal · Imdur, Ismo
- Romania · Mononitron Ep, Olicard Retard
- Sweden · Imdur, Ismo
- Slovenia · Monosan, Olicard
- Slovakia · Mono Mack Depot, Monosan
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/48ebacf4-0e5a-45ca-8fcf-2448565b7b7a GET /v1/drugs/48ebacf4-0e5a-45ca-8fcf-2448565b7b7a?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. Tratamiento De Larga Duración",
"estado": "{\"aut\":596934000000}",
"nregistro": "58078",
"substance": "mononitrato de isosorbida"
}See everything about mononitrato de isosorbida.
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.