France· FR:66296030
ROACCUTANE 0,05 POUR CENT, gel pour application locale
A medicinal product containing isotrétinoïne, registered in France by SERP.
Checked against Base de données publique des médicaments — BDPM (France) on
Informational only — not a medical device.
The record
At a glance
Base de données publique des médicaments — BDPM (France)- Active substance
- ISOTRÉTINOÏNE
- Manufacturer
- SERP
- Country
- France (FR)
- ATC code
- —
- Reimbursed
- No
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 1
- cip1334009334717051 tube(s) aluminium verni de 30 g
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Isotrétinoïne in 17 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesAbsoricaSun Pharmaceutical Industries, Inc.
- United KingdomIsotretinoin 10mg capsulesSun Pharma UK Ltd
- CzechiaAKNENORMINAlmirall Hermal GmbH, Reinbek
- SwitzerlandCurakne
- PolandAknenormin 10 mgAlmirall Hermal GmbH
- SpainACNEMIN 10 mg CAPSULAS BLANDASLaboratorios Vinas S.A.
- FinlandCuracné
- ItalyAISOSKINFIDIA FARMACEUTICI S.P.A.
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
- Spain · Acnemin 10 Mg, Acnemin 20 Mg
- Finland · Isotretinoin Actavis, Isotretinoin Orifarm
- 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 Base de données publique des médicaments — BDPM (France). 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/f5cf4c2c-2563-4880-8c97-bfd3e32e8ad7 GET /v1/drugs/f5cf4c2c-2563-4880-8c97-bfd3e32e8ad7?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.
{
"cis": "66296030",
"date_amm": "1992-02-11",
"type_amm": "Procédure nationale",
"numero_ue": null,
"substance": "ISOTRÉTINOÏNE",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "gel pour application",
"voies_administration": "cutanée",
"etat_commercialisation": "Commercialisée",
"surveillance_renforcee": "Non"
}See everything about isotrétinoïne.
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.