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Netherlands· NL-4e0f414e4c23

Prothiaden Mitis 25, capsules 25 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 Mitis 25, capsules 25 mgATCN06AA16REGISTER NO.NL-4e0f414e4c23PACKS LISTED1CHECKEDSeptember 29, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about dosulepinehydrochlorideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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
Search dosulepin products by name

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
    09997

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
Check dosulepin against other medicinesHow interaction checks work

Dosulepin · interactions on record

5 records

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

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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/5dd3f39c-ccb4-4e99-b42e-c72771b9d5e7
GET /v1/drugs/5dd3f39c-ccb4-4e99-b42e-c72771b9d5e7?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, hard",
  "route": "Oraal gebruik",
  "soort": "RVG",
  "source": "cbg_meb",
  "smpc_url": "https://www.geneesmiddeleninformatiebank.nl/smpc/h09997_smpc.pdf",
  "strength": null,
  "atc_label": "Dosulepin",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/rvg09997",
  "excipients": [
    "GELATINE (E 441)",
    "IJZEROXIDE ZWART (E 172)",
    "LACTOSE 1-WATER",
    "LECITHINE (E 322)",
    "MAGNESIUMSTEARAAT (E 470b)",
    "MAÏSZETMEEL",
    "SCHELLAK (E 904)",
    "SILICONEN ANTISCHUIM DC 1510",
    "TITAANDIOXIDE (E 171)",
    "ZWARTE INKT"
  ],
  "substances": [
    "DOSULEPINEHYDROCHLORIDE"
  ],
  "leaflet_url": "https://www.geneesmiddeleninformatiebank.nl/bijsluiters/h09997.pdf",
  "authorised_at": "1983/10/06",
  "procedure_number": null,
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "09997",
  "additional_monitoring": "N"
}
API referenceMCP serverPlans

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.

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