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Germany· DE-A57-2c46f61c7fd0770e

Isotiorga

A isotretinoin product containing isotretinoin, registered in Germany by Laboratoires Bailleul S.A.. The same ATC class is registered in 3 of our 19 countries.

ATC Isotretinoin

Checked against EMA Article 57 (European Union) on

Informational only — not a medical device.

SOURCE REGISTER · DEEMA Article 57 (European Union)normalisedIsotiorgaATCIsotretinoinREGISTER NO.DE-A57-2c46f61c7fd077…PACKS LISTED0CHECKEDSeptember 30, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about isotretinoinAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Isotretinoin is registered in 3 of 19 countries.

Countries holding a registration under ATC Isotretinoin (isotretinoin), each read from that country’s own register.

  • This record: Germany, from EMA Article 57 (European Union)
  • 1 of them publish a price we can compare per daily dose
Search isotretinoin products by name

Isotretinoin · ATC Isotretinoin

3 / 19 countries

  • Germany
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

EMA Article 57 (European Union)
Active substance
Isotretinoin
Manufacturer
Laboratoires Bailleul S.A.
Country
Germany (DE)
ATC code
Isotretinoin
ATC class
Isotretinoin
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

Isotretinoin in 17 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All isotretinoin products

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
  • Denmark · Acnenor, Isomacne
  • Estonia · Isotiorga, Isotretinoin Sandoz
  • Spain · Acnemin 10 Mg, Acnemin 20 Mg
  • 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 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/89ebfb76-9c01-4780-aad7-9ade6289a42e
GET /v1/drugs/89ebfb76-9c01-4780-aad7-9ade6289a42e?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": "Oral Use",
  "source": "ema_art57_de",
  "ma_number": null,
  "substance": "Isotretinoin",
  "atc_from_source": null,
  "authorisation_country": "Germany"
}
API referenceMCP serverPlans

See everything about isotretinoin.

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.

Try it freeOpen in the console