Spain· ES:66160
FLEXRESAN 10 mg CAPSULAS BLANDAS
A medicinal product containing isotretinoína, registered in Spain by Especialidades Farmaceuticas Centrum S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- isotretinoína
- Manufacturer
- Especialidades Farmaceuticas Centrum 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_codigo73482250EUR 17.09
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Isotretinoína in 17 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaAKNENORMINAlmirall Hermal GmbH, Reinbek
- NorwayAknenorminAlmirall
- PolandAknenormin 10 mgAlmirall Hermal GmbH
- United StatesClaravisTeva Pharmaceuticals USA, Inc.
- FinlandIsotretinoin ActavisActavis Group PTC ehf
- SwedenIsotracin 10 mg Kapsel, mjuk2care4 Generics ApS
- IrelandIsotretinoin 10 mg soft capsulesRowex Limited,
- FranceCONTRACNE 10 mg, capsule molleLABORATOIRES BAILLEUL (LUXEMBOURG)
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · Aknenormin®, Ciscutan
- Belgium · Isocural, Isosupra Lidose
- Bulgaria · Роакутан
- Cyprus · Acmotren, Isotroin
- Czechia · Aknenormin, Asotiorga
- Germany · Aknenormin, Isogalen
- Denmark · Acnenor, Isomacne
- Estonia · Isotiorga, Isotretinoin Sandoz
- Finland · Isotretinoin Actavis, Isotretinoin Orifarm
- France · Acnetrait, Contracne
- United Kingdom (Northern Ireland) · Isotretinoin Ennogen Ip, Isotretinoin Sun Pharmaceutical Industries Europe
- Greece · A-Cnotren, Acnesyn
- Croatia · Roaccutane
- Hungary · Inerta, Isotiorga
- Ireland · Isotretinoin Gap, Isotretinoin Rowex
- Iceland · Decutan
- Italy · Aisoskin, Isdiben
- Lithuania · Isotretinoin Sandoz, Roaccutane
- Luxembourg · Isotiorga, Roaccutane
- Latvia · Isotretinoin Sandoz, Roaccutane
- Malta · Contracne, Isotretinoin
- Netherlands · Isotretinoine Aurobindo, Isotretinoïne Doc
- Norway · Isotretinoin Orifarm, Isotretinoin Sandoz
- Poland · Aknenormin, Axotret
- Portugal · Isotiorga, Isotretinoína Aurovitas
- Romania · Isotiorga, Roaccutane
- Sweden · Isotracin, Isotretinoin Actavis
- Slovenia · Retitren
- Slovakia · Aknenormin 10, Aknenormin 20
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/7dab07a1-3c47-4b2b-a3a8-776db3c80bcd GET /v1/drugs/7dab07a1-3c47-4b2b-a3a8-776db3c80bcd?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": "Diagnóstico Hospitalario",
"estado": "{\"aut\":1087855200000}",
"nregistro": "66160",
"substance": "isotretinoína"
}See everything about isotretinoína.
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.