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.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
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
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
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_apb4616066EUR 15.77
- be_apb4616082EUR 32.52
- be_apb4616074EUR 22.57
- be_apb7736614
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.
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.
- CzechiaAKNENORMINAlmirall Hermal GmbH, Reinbek
- NorwayAknenorminAlmirall
- PolandAknenormin 10 mgAlmirall Hermal GmbH
- United StatesClaravisTeva Pharmaceuticals USA, Inc.
- SpainACNEMIN 10 mg CAPSULAS BLANDASLaboratorios Vinas S.A.
- FinlandIsotretinoin ActavisActavis Group PTC ehf
- SwedenIsotracin 10 mg Kapsel, mjuk2care4 Generics ApS
- IrelandIsotretinoin 10 mg soft capsulesRowex Limited,
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.