Germany· DE-A57-5512a602c04e1904

Bosentan Puren

A bosentan product containing bosentan, registered in Germany by Puren Pharma Gmbh & Co. Kg. The same ATC class is registered in 18 of our 19 countries.

ATC C02KX01

Checked against EMA Article 57 (European Union) on

Informational only — not a medical device.

SOURCE REGISTER · DEEMA Article 57 (European Union)normalisedBosentan PurenATCC02KX01REGISTER NO.DE-A57-5512a602c04e19…PACKS LISTED0CHECKEDSeptember 30, 2026

Where it is registered

Bosentan is registered in 18 of 19 countries.

Countries holding a registration under ATC C02KX01 (bosentan), each read from that country’s own register.

  • This record: Germany, from EMA Article 57 (European Union)
  • 11 of them publish a price we can compare per daily dose

Bosentan · ATC C02KX01

18 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • Sweden
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
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.

Price per daily dose

What a daily dose of bosentan costs, country by country.

Normalised to the WHO defined daily dose (0.25 g), the median price runs from $25.92 in Italy to $66.51 in Switzerland — a ×2.6 gap.

  • 2 markets with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown

Bosentan · price per daily dose (0.25 g)

USD · FX 28 Sept 2026

  • CH Switzerland$66.51
  • IT Italy$25.92
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

EMA Article 57 (European Union)
Active substance
Bosentan
Manufacturer
Puren Pharma Gmbh & Co. Kg
Country
Germany (DE)
ATC code
C02KX01
ATC class
Bosentan
Defined daily dose
0.25 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

355 interactions on record for bosentan.

Graded by severity as the source publishes them — 45 severe. Severity grades are free for everyone; mechanism and management come 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

Bosentan · interactions on record

355 records

  • 45 severe
  • 227 moderate
  • 7 minor
  • 69 info

Most severe, free to view

  • GlibenclamideA10BB01severe
  • Levonorgestrel and ethinylestradiolG03AA07severe
  • Desogestrel and ethinylestradiolG03AA09severe
  • Drospirenone and ethinylestradiolG03AA12severe

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

Sign in to check
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Bosentan in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All bosentan products

Authorised across Europe · EMA

The same active substance is authorised in 29 EEA countries. Names it is sold under:

  • Austria · Bosentan Accord, Bosentan Reddy
  • Belgium · Bosentan Accord, Bosentan Sandoz
  • Bulgaria · Bosentan Sdz, Бозентан Акорд
  • Cyprus · Bactoced, Bosentan Accord
  • Czechia · Bosentan Abdi, Bosentan Accord
  • Denmark · Bosentan Accord, Bosentan Cipla
  • Estonia · Bosentan Accord, Bosentan Norameda
  • Spain · Bosentan Accordpharma, Bosentán Accordpharma
  • Finland · Bosentan Accord
  • France · Bosentan Accord, Bosentan Arrow
  • United Kingdom (Northern Ireland) · Bosentan Accord, Bosentan Generics [uk]
  • Greece · Bocleer, Klimurtan
  • Croatia · Bosentan Cipla, Bosentan Makpharm
  • Hungary · Bosentan Pharmascience
  • Ireland · Bosentan Accord, Bosentan Zentiva
  • Iceland · Stayveer, Tracleer
  • Italy · Bosentan Abdi, Bosentan Accord
  • Liechtenstein · Stayveer, Tracleer
  • Lithuania · Bosentan Accord, Bosentan Norameda
  • Latvia · Bosentan Accord, Bosentan Norameda
  • Malta · Bosentan Aurobindo
  • Netherlands · Bosentan Abdi, Bosentan Accord
  • Norway · Bosentan Accord, Bosentan Cipla
  • Poland · Bopaho, Bosentan Accord
  • Portugal · Bosentano Accord, Bosentano Aurobindo
  • Romania · Bopaho, Bosentan Accord
  • Sweden · Bosentan Accord, Bosentan Sandoz
  • Slovenia · Bosentan Norameda
  • Slovakia · Bosentan Accord

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/fb401455-ad5e-4a76-8078-56581491c0ea
GET /v1/drugs/fb401455-ad5e-4a76-8078-56581491c0ea?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": "Bosentan",
  "atc_from_source": null,
  "authorisation_country": "Germany"
}

See everything about bosentan.

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.