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Ireland· IE-PA-PA22871/013/001

Dosulepin Hydrochloride 25 mg Hard Capsules

A dosulepin product containing dosulepin hydrochloride, registered in Ireland by Azure Pharmaceuticals Ltd.. The same ATC class is registered in 7 of our 19 countries.

ATC N06AA16

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedDosulepin Hydrochloride 25 mg Hard Ca…ATCN06AA16REGISTER NO.IE-PA-PA22871/013/001PACKS LISTED1CHECKEDSeptember 28, 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: Ireland, from HPRA (Ireland)
  • 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

HPRA (Ireland)
Active substance
Dosulepin hydrochloride
Manufacturer
Azure Pharmaceuticals Ltd.
Country
Ireland (IE)
ATC code
N06AA16
ATC class
Dosulepin
Defined daily dose
0.15 g, O
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PA22871/013/001

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:

  • Belgium · Prothiaden
  • Czechia · Prothiaden
  • Germany · Idom, Idom Mite
  • Denmark · Prothiaden
  • France · Prothiaden
  • United Kingdom (Northern Ireland) · Dosulepin, Dosulepin Cadila Pharmaceuticals (Uk)
  • 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 HPRA (Ireland). 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/92869740-d78d-41cd-8840-6411ed19e2f7
GET /v1/drugs/92869740-d78d-41cd-8840-6411ed19e2f7?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",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "N06AA16"
  ],
  "strength": null,
  "pa_number": "PA22871/013/001",
  "substances": [
    "Dosulepin hydrochloride"
  ],
  "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)",
  "market_info": "Not marketed",
  "authorised_at": "05/08/2022",
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}
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