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Netherlands· NL-e961b4c4e462

Prothiaden 75, dragees 75 mg

A dosulepin product containing dosulepinehydrochloride, registered in Netherlands by Teofarma Srl. The same ATC class is registered in 7 of our 19 countries.

ATC N06AA16

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedProthiaden 75, dragees 75 mgATCN06AA16REGISTER NO.NL-e961b4c4e462PACKS LISTED1CHECKEDSeptember 29, 2026

Where it is registered

Dosulepin is registered in 7 of 19 countries.

Countries holding a registration under ATC N06AA16 (dosulepin), each read from that country’s own register.

  • This record: Netherlands, from CBG-MEB (Netherlands)
  • 2 of them publish a price we can compare per daily dose

Dosulepin · ATC N06AA16

7 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Germany
  • Ireland
  • Netherlands
  • 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.

The record

At a glance

CBG-MEB (Netherlands)
Active substance
DOSULEPINEHYDROCHLORIDE
Manufacturer
Teofarma Srl
Country
Netherlands (NL)
ATC code
N06AA16
ATC class
Dosulepin
Defined daily dose
0.15 g, O
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    09998

Regulatory notes

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

Interactions

5 interactions on record for dosulepin.

Mechanism, severity and management for each pair, from a commercially licensed source — included 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

Dosulepin · interactions on record

5 records

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

Sign in to check
Mechanism and what to do, in the interaction check
Interaction register. Grades as the source publishes them.

Same medicine, other countries

Dosulepin in 6 other countries

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

All dosulepin products

Authorised across Europe · EMA

The same active substance is authorised in 11 EEA countries. Names it is sold under:

  • Belgium · Prothiaden
  • Czechia · Prothiaden
  • Germany · Idom, Idom Mite
  • Denmark · Prothiaden
  • France · Prothiaden
  • United Kingdom (Northern Ireland) · Dosulepin, Dosulepin Cadila Pharmaceuticals (Uk)
  • Ireland · Dosulepin Hydrochloride Azure Pharmaceuticals, Dosulepin Hydrochloride Azure Pharmaceuticals Ltd
  • Italy · Protiaden
  • Luxembourg · Prothiaden
  • Portugal · Protiadene
  • Slovakia · Prothiaden

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 CBG-MEB (Netherlands). 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/4d66253e-1363-4e62-98f0-24fbc5504249
GET /v1/drugs/4d66253e-1363-4e62-98f0-24fbc5504249?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": "Omhulde tablet",
  "route": "Oraal gebruik",
  "soort": "RVG",
  "source": "cbg_meb",
  "smpc_url": "https://www.geneesmiddeleninformatiebank.nl/smpc/h09998_smpc.pdf",
  "strength": null,
  "atc_label": "Dosulepin",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/rvg09998",
  "excipients": [
    "CARNAUBAWAS (E 903)",
    "GLUCOSE, VLOEIBAAR",
    "IJZEROXIDE ZWART (E 172)",
    "LECITHINE (E 322)",
    "MAGNESIUMSTEARAAT (E 470b)",
    "MAÏSZETMEEL",
    "NATRIUMBENZOAAT (E 211)",
    "POVIDON (E 1201)",
    "SACCHAROSE",
    "SCHELLAK (E 904)",
    "TALK (E 553b)",
    "TITAANDIOXIDE (E 171)",
    "TRICALCIUMFOSFAAT (E 341 (iii))",
    "ZWARTE INKT"
  ],
  "substances": [
    "DOSULEPINEHYDROCHLORIDE"
  ],
  "leaflet_url": "https://www.geneesmiddeleninformatiebank.nl/bijsluiters/h09998.pdf",
  "authorised_at": "1983/10/06",
  "procedure_number": null,
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "09998",
  "additional_monitoring": "N"
}

See everything about dosulepin.

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.