Spain· ES:89193
HIDROXICARBAMIDA MEDAC 500 MG CÁPSULAS DURAS
A medicinal product containing hidroxicarbamida, registered in Spain by Medac Gesellschaft Für Klinische Spezialpräparate Gmbh.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- hidroxicarbamida
- Manufacturer
- Medac Gesellschaft Für Klinische Spezialpräparate Gmbh
- 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
Hidroxicarbamida in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesHYDREAWaylis Therapeutics LLC
- United KingdomHydrea 500mg capsulesMawdsley-Brooks & Company Ltd
- FinlandHydreaCheplapharm Arzneimittel GmbH
- SwitzerlandHydroxycarbamid Devatis
- NetherlandsHydroxycarbamide Devatis 500mg, harde capsulesDevatis GmbH
- NorwayHydreaCheplapharm
- CanadaAPO-HYDROXYUREAAPOTEX INC
- PolandHydroxycarbamid EugiaEugia Pharma (Malta) Ltd.
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Ardjaq, Hydroxycarbamid Devatis
- Belgium · Hydrea
- Bulgaria · Хидреа
- Cyprus · Hydreasyn
- Czechia · Litalir
- Germany · Ardjaq, Hydroxycarbamid 1 A Pharma
- Denmark · Hydroxyurea Medac, Oribamide
- Estonia · Hydrea
- Finland · Hydrea, Hydroxyurea Medac
- France · Hydrea, Hydroxycarbamide Arrow
- United Kingdom (Northern Ireland) · Hydrea, Hydroxycarbamide
- Greece · Hydreasyn
- Croatia · Litalir, Xybaid
- Hungary · Hydroxycarbamide Pharmacenter, Litalir
- Ireland · Hydrea
- Iceland · Hydroxyurea Medac, Siklos
- Italy · Idrossicarbamide Aurobindo, Onco Carbide
- Liechtenstein · Siklos
- Lithuania · Hydrea
- Luxembourg · Hydrea, Hydroxycarbamid Devatis
- Latvia · Hydrea
- Malta · Hydroxycarbamide Eugia
- Netherlands · Hydroxycarbamide Devatis, Hydroxycarbamide Eugia
- Norway · Hydroxyurea Medac, Oribamide
- Poland · Hydroxycarbamid Eugia, Hydroxycarbamid Teva
- Portugal · Hidroxicarbamida Generis, Hidroxicarbamida Hikma
- Romania · Hydrea
- Sweden · Hydrea, Hydroxyurea Medac
- Slovenia · Hidroksisečnina Aptapharma, Litalir
- Slovakia · Hydroxykarbamid Medac, Xybaid
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/d6db99d4-a382-40bf-872f-fe98625ba557 GET /v1/drugs/d6db99d4-a382-40bf-872f-fe98625ba557?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\":1702548457000}",
"nregistro": "89193",
"substance": "hidroxicarbamida"
}See everything about hidroxicarbamida.
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.