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Belgium· BE-AMP-SAM104964-00

Prothiaden 25 mg

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

ATC N06AA16

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedProthiaden 25 mgATCN06AA16REGISTER NO.BE-AMP-SAM104964-00PACKS LISTED3CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about dosulepin hydrochlorideAnswers 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: Belgium, from FAMHP / AFMPS (Belgium)
  • 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

FAMHP / AFMPS (Belgium)
Active substance
Dosulepin Hydrochloride
Manufacturer
Teofarma
Country
Belgium (BE)
ATC code
N06AA16
ATC class
Dosulepin
Defined daily dose
0.15 g, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 3

1 priced
  • be_apb
    0072702
    EUR 11.01
  • be_apb
    0072686
  • be_apb
    0715987

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.

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:

  • 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
  • Netherlands · Prothiaden, Prothiaden Mitis
  • 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 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/5a8f902f-3c73-404e-999b-c3a5bfc688ec
GET /v1/drugs/5a8f902f-3c73-404e-999b-c3a5bfc688ec?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",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Prothiaden 25 mg",
  "name_fr": "Prothiaden 25 mg",
  "name_nl": "Prothiaden 25 mg",
  "amp_code": "SAM104964-00",
  "strengths": [
    "25.0000",
    "22.2500",
    "106.0000"
  ],
  "pack_count": 2,
  "substances": [
    "Dosulepin Hydrochloride",
    "Dosulepin",
    "Lactose"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Dosulepin",
  "authorisation_numbers": [
    "BE104964"
  ]
}
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.

Try it freeOpen in the console