Spain· ES:82398
SOFTACORT 3,35 MG/ML COLIRIO EN SOLUCION EN ENVASES UNIDOSIS
A medicinal product containing hidrocortisona, registered in Spain by Laboratoires Thea.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- hidrocortisona
- Manufacturer
- Laboratoires Thea
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 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
Hidrocortisona in 18 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United States1% Hydrocortisone Anti-itchALAINA HEALTHCARE PRIVATE LIMITED
- United KingdomAlkindi 0.5mg granules in capsules for openingNeurocrine UK Ltd
- NetherlandsAcecort 1 mg, filmomhulde tablettenACE Pharmaceuticals B.V.
- PolandAkortorOrion Corporation
- FinlandAlcortNextmune Italy S.r.l.
- SwedenAlkindi 0,5 mg Granulat i kapsel avsedd att öppnasImmedica Pharma AB
- GermanyAcecortAce Pharmaceuticals Bv
- NorwayAcecortOrifarm AS
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Ekzemsalbe „f“, Hydrocortison
- Belgium · Acecort, Cremicort
- Bulgaria · Хидрокортизон Ромфарм
- Cyprus · Cortopin, Dermaid
- Czechia · Hydrocortison Léčiva, Hydrocortison Vuab
- Germany · Acecort, Ebenol Für Erwachsene Und Kinder Ab 6 Jahren
- Denmark · Hydrocortison Strides, Hydrocortisone Activase
- Estonia · Abix, Hydrocortisone Dak
- Finland · Ampikyy, Hydrocortison Orion
- France · Colofoam, Corazed
- United Kingdom (Northern Ireland) · Colifoam, Corlan
- Greece · Drosone, Edicot
- Croatia · Cortef, Cortovex
- Hungary · Cortef, Hikomicron
- Ireland · Cortopin 1% W/W Cream, Hc45
- Iceland · Alkindi, Efmody
- Italy · Cortidro, Dermirit
- Liechtenstein · Alkindi, Efmody
- Lithuania · Hydrocortisone Orifarm
- Luxembourg · Cortisedermyl, Cremicort
- Latvia · Hydrocortisone Renata, Hydrocortisonum Pharmaswiss
- Malta · Carplexil, Hydrokortyzon Allefin Max
- Netherlands · Acecort, Hydrocortison
- Norway · Alkindi, Efmody
- Poland · Akortor, Dermocort
- Portugal · Carplexil, Hidrocortisona Bluepharma
- Romania · Hidrocortizon Atb, Hidrocortizon Fiterman
- Sweden · Ficortril, Hydrocortisone Activase
- Slovenia · Hidrokortizon Altamedics, Hidrokortizon Orion
- Slovakia · Cortovex, Hydrocortison Léčiva
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/b15812e7-1c05-4398-a29e-a2baebb71a1c GET /v1/drugs/b15812e7-1c05-4398-a29e-a2baebb71a1c?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\":1505080800000}",
"nregistro": "82398",
"substance": "hidrocortisona"
}See everything about hidrocortisona.
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.