Germany· DE-A57-aca5d4b1c2db8388
Idom Mite
A dosulepin product containing dosulepin hydrochloride, registered in Germany by Pharmaselect International Beteiligungs Gmbh. The same ATC class is registered in 7 of our 19 countries.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
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: Germany, from EMA Article 57 (European Union)
- 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
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Dosulepin Hydrochloride
- Manufacturer
- Pharmaselect International Beteiligungs Gmbh
- Country
- Germany (DE)
- ATC code
- N06AA16
- ATC class
- Dosulepin
- Defined daily dose
- 0.15 g, O
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 2026
Packs & prices · 0
No packs listed by the register for this record.
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 checkSame 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.
- United KingdomDosulepin 100mg/5ml oral solutionSpecial Order
- IrelandDosulepin Hydrochloride 25 mg Hard CapsulesAzure Pharmaceuticals Ltd.
- BelgiumProthiaden 25 mgTeofarma
- FrancePROTHIADEN 25 mg, géluleTEOFARMA
- CzechiaPROTHIADENZentiva, k.s., Praha
- NetherlandsProthiaden 75, dragees 75 mgTeofarma Srl
Authorised across Europe · EMA
The same active substance is authorised in 11 EEA countries. Names it is sold under:
- Belgium · Prothiaden
- Czechia · Prothiaden
- 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 EMA Article 57 (European Union). 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/ecc581ca-dccb-45a6-b216-2a1d57a46579 GET /v1/drugs/ecc581ca-dccb-45a6-b216-2a1d57a46579?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.
{
"pzn": null,
"route": "Oral Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Dosulepin Hydrochloride",
"atc_from_source": null,
"authorisation_country": "Germany"
}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.