Czechia· CZ-0004071

DITHIADEN

A other antihistamines for systemic use product containing bisulepin hydrochloride, registered in Czechia by Zentiva, k.s., Praha. The same ATC class is registered in 3 of our 19 countries.

ATC R06AX

Checked against SÚKL (Czech Republic) on

Informational only — not a medical device.

SOURCE REGISTER · CZSÚKL (Czech Republic)normalisedDITHIADENATCR06AXREGISTER NO.CZ-0004071PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Bisulepin hydrochloride is registered in 3 of 19 countries.

Countries holding a registration under ATC R06AX (other antihistamines for systemic use), each read from that country’s own register.

  • This record: Czechia, from SÚKL (Czech Republic)
  • 1 of them publish a price we can compare per daily dose

Bisulepin hydrochloride · ATC R06AX

3 / 19 countries

  • Canada
  • Czechiaprice
  • Ireland
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

SÚKL (Czech Republic)
Active substance
BISULEPIN HYDROCHLORIDE
Manufacturer
Zentiva, k.s., Praha
Country
Czechia (CZ)
ATC code
R06AX
ATC class
Other antihistamines for systemic use
Reimbursed
Not published by this register
Source register
SÚKL (Czech Republic)
Last checked
September 28, 2026

Packs & prices · 1

1 priced
  • cz_kod_sukl
    0004071
    10X2ML
    CZK 420.77

Regulatory notes

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

Same class

Other records under R06AX

Other antihistamines for systemic use, as other registers publish it.

All bisulepin hydrochloride products

Authorised across Europe · EMA

The same active substance is authorised in 1 EEA country. Names it is sold under:

  • Slovakia · Dithiaden, Dithiaden Inj

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 SÚKL (Czech Republic). 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/b4a28a4f-f240-4429-aa59-4fe79ac4c3bd
GET /v1/drugs/b4a28a4f-f240-4429-aa59-4fe79ac4c3bd?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": "INJ SOL",
  "source": "sukl",
  "strength": "0,5MG/ML",
  "pack_size": "10X2ML",
  "substance": "BISULEPIN HYDROCHLORIDE",
  "cz_kod_sukl": "0004071",
  "product_type": "CH",
  "substance_codes": "1644",
  "registration_state": "R",
  "registration_number": "24/170/79-C"
}

See everything about bisulepin hydrochloride.

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.