Belgium· BE-AMP-SAM596071-00

Isotiorga 10 mg

A isotretinoin product containing isotretinoin, registered in Belgium by Laboratoires Bailleul. The same ATC class is registered in 13 of our 19 countries.

ATC D10BA01

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedIsotiorga 10 mgATCD10BA01REGISTER NO.BE-AMP-SAM596071-00PACKS LISTED4CHECKEDSeptember 26, 2026

Where it is registered

Isotretinoin is registered in 13 of 19 countries.

Countries holding a registration under ATC D10BA01 (isotretinoin), each read from that country’s own register.

  • This record: Belgium, from FAMHP / AFMPS (Belgium)
  • 8 of them publish a price we can compare per daily dose

Isotretinoin · ATC D10BA01

13 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
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.

Price per daily dose

What a daily dose of isotretinoin costs, country by country.

Normalised to the WHO defined daily dose (30 mg), the median price runs from $1.27 in Italy to $2.18 in Switzerland — a ×1.7 gap.

  • 2 markets with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown

Isotretinoin · price per daily dose (30 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$2.18
  • IT Italy$1.27
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Isotretinoin
Manufacturer
Laboratoires Bailleul
Country
Belgium (BE)
ATC code
D10BA01
ATC class
Isotretinoin
Defined daily dose
30 mg, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 4

3 priced
  • be_apb
    4616066
    EUR 15.77
  • be_apb
    4616082
    EUR 32.52
  • be_apb
    4616074
    EUR 22.57
  • be_apb
    7736614

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

127 interactions on record for isotretinoin.

Graded by severity as the source publishes them — 21 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Isotretinoin · interactions on record

127 records

  • 21 severe
  • 96 moderate

Most severe, free to view

  • MipomersenC10AX11severe
  • LomitapideC10AX12severe
  • AcitretinD05BB02severe
  • DemeclocyclineJ01AA01severe

10 more interactions with mechanism and management, from a commercially licensed source.

Sign in to check
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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
  • 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
  • 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 FAMHP / AFMPS (Belgium). 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/c850a6b0-4457-41a2-a5f8-ee4819059dfd
GET /v1/drugs/c850a6b0-4457-41a2-a5f8-ee4819059dfd?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.

{
  "form": "Capsule, soft",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Isotiorga 10 mg",
  "name_fr": "Isotiorga 10 mg",
  "name_nl": "Isotiorga 10 mg",
  "amp_code": "SAM596071-00",
  "strengths": [
    "10.0000",
    "10.0000",
    "0.0440",
    "28.7001",
    "7.6800",
    "108.4118",
    "7.2180",
    "30.7200"
  ],
  "pack_count": 4,
  "substances": [
    "Isotretinoin",
    "E 124",
    "Glycerol",
    "Glycine max - Glycine soja (Ph.Eur. mixture), Bean, Oil - Hydrogenated",
    "Glycine max - Glycine soja (Ph.Eur. mixture), Bean, Oil - Refined",
    "Sorbitol Liquid",
    "Vegetable Oil, Hydrogenated"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Isotretinoin",
  "authorisation_numbers": [
    "BE596071"
  ]
}

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.