Poland· PL-100307528

Izotek 10 mg

A isotretinoin product containing isotretinoinum, registered in Poland by Delfarma Sp. z o.o.. The same ATC class is registered in 13 of our 19 countries.

ATC D10BA01

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedIzotek 10 mgATCD10BA01REGISTER NO.PL-100307528PACKS LISTED4CHECKEDSeptember 27, 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: Poland, from URPL (Poland)
  • 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

URPL (Poland)
Active substance
Isotretinoinum
Manufacturer
Delfarma Sp. z o.o.
Country
Poland (PL)
ATC code
D10BA01
ATC class
Isotretinoin
Defined daily dose
30 mg, O
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 4

  • gtin
    05909997228747
  • gtin
    05909997228754
  • gtin
    05909997228761
  • gtin
    05909997228778

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
  • 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
  • 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
  • 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 URPL (Poland). 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/fb3e784f-6218-45b5-a7b0-b040f5f0fd4a
GET /v1/drugs/fb3e784f-6218-45b5-a7b0-b040f5f0fd4a?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": "Kapsułki miękkie",
  "source": "urpl",
  "strength": "10 mg",
  "packaging": "05909997228747 ¦ Rp ¦ 87638\n10 kaps.\n05909997228754 ¦ Rp ¦ 87754\n30 kaps.\n05909997228761 ¦ Rp ¦ 87813\n60 kaps.\n05909997228778 ¦ Rp ¦ 87834\n100 kaps.",
  "substance": null,
  "common_name": "Isotretinoinum",
  "pl_product_id": "100307528",
  "pozwolenie_nr": "543/13",
  "auth_procedure": "IR",
  "authorisation_validity": "2028-12-16"
}

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.