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Sweden· SE-20190328000036

Isotracin 10 mg Kapsel, mjuk

A medicinal product containing isotretinoin, registered in Sweden by 2care4 Generics ApS.

Checked against Swedish Medical Products Agency (Sweden) on

Informational only — not a medical device.

SOURCE REGISTER · SESwedish Medical Products Agency (Sweden)normalisedIsotracin 10 mg Kapsel, mjukATC—REGISTER NO.SE-20190328000036PACKS LISTED1CHECKEDOctober 1, 2026

The record

At a glance

Swedish Medical Products Agency (Sweden)
Active substance
Isotretinoin
Manufacturer
2care4 Generics ApS
Country
Sweden (SE)
ATC code
—
Reimbursed
Not published by this register
Source register
Swedish Medical Products Agency (Sweden)
Last checked
October 1, 2026

Packs & prices · 1

  • se_varunummer
    20190328000036

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
  • 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
  • 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 Swedish Medical Products Agency (Sweden). 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/adfa25dd-61c6-44f2-afa9-671dd998d1cb
GET /v1/drugs/adfa25dd-61c6-44f2-afa9-671dd998d1cb?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.

{
  "source": "lakemedelsverket",
  "doc_types": [
    "SmPC",
    "PL"
  ],
  "se_npl_id": "20190328000036",
  "product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20190328000036",
  "product_doc_link": "https://docetp.mpa.se/LMF/Isotracin%20capsule%2C%20soft%20SmPC_09001bee851e4d77.pdf"
}

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.