Germany· DE-A57-f4644726153d70de
Softacort
A medicinal product containing hydrocortisone sodium phosphate, registered in Germany by Laboratoires Thea.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Hydrocortisone Sodium Phosphate
- Manufacturer
- Laboratoires Thea
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 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
Hydrocortisone sodium phosphate in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaSOFTACORTLaboratoires Thea, Clermont-Ferrand
- IrelandSolu-Cortef 100 mg Powder for Solution for Injection or InfusionPfizer Healthcare Ireland Unlimited Company
- BelgiumSoftacor 3.35 mg/mlLaboratoires Théa
- FinlandSoftacortLaboratoires THEA
- NorwaySoftacortLaboratoires Thea S.A.S
- SwedenSoftacort 3,35 mg/ml Ögondroppar, lösning i endosbehållareLaboratoires THEA
Authorised across Europe · EMA
The same active substance is authorised in 24 EEA countries. Names it is sold under:
- Austria · Softacort
- Belgium · Softacor
- Bulgaria · Софтакорт
- Cyprus · Cortizi® Preservative Free, Eping
- Czechia · Softacort
- Denmark · Softacort
- Spain · Actocortina, Softacort
- Finland · Softacort
- France · Lenaster, Softacort
- United Kingdom (Northern Ireland) · Efcortesol, Hydrocortisone Amdipharm Uk
- Greece · Cortizi, Cortizi (Preservative Free)
- Croatia · Softacort
- Ireland · Zoftacot
- Iceland · Softacort
- Italy · Cortivis, Sofacor
- Luxembourg · Softacor
- Netherlands · Softacor
- Norway · Softacort
- Poland · Softacort
- Portugal · Softacort
- Romania · Softacort
- Sweden · Softacort
- Slovenia · Softacort
- Slovakia · Softacort
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 EMA Article 57 (European Union). 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/55d52032-6050-4121-9cb9-214f456aed50 GET /v1/drugs/55d52032-6050-4121-9cb9-214f456aed50?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.
{
"pzn": null,
"route": "Ocular Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Hydrocortisone Sodium Phosphate",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about hydrocortisone sodium phosphate.
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.