Poland· PL-100440196

Xenleta

A lefamulin product containing lefamulinum, registered in Poland by Nabriva Therapeutics Ireland DAC. The same ATC class is registered in 9 of our 19 countries.

ATC J01XX12

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedXenletaATCJ01XX12REGISTER NO.PL-100440196PACKS LISTED0CHECKEDSeptember 27, 2026

Where it is registered

Lefamulin is registered in 9 of 19 countries.

Countries holding a registration under ATC J01XX12 (lefamulin), each read from that country’s own register.

  • This record: Poland, from URPL (Poland)
  • 6 of them publish a price we can compare per daily dose

Lefamulin · ATC J01XX12

9 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Polandprice
  • 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.

The record

At a glance

URPL (Poland)
Active substance
Lefamulinum
Manufacturer
Nabriva Therapeutics Ireland DAC
Country
Poland (PL)
ATC code
J01XX12
ATC class
Lefamulin
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 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

362 interactions on record for lefamulin.

Graded by severity as the source publishes them — 133 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

Lefamulin · interactions on record

362 records

  • 133 severe
  • 227 moderate
  • 2 minor

Most severe, free to view

  • PapaverineA03AD01severe
  • CisaprideA03FA02severe
  • OndansetronA04AA01severe
  • GranisetronA04AA02severe
  • 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

Lefamulin in 8 other countries

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

All lefamulin products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Xenleta
  • Liechtenstein · Xenleta
  • Norway · Xenleta

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 URPL (Poland). 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/fba57b29-5289-4958-91c9-035746950c04
GET /v1/drugs/fba57b29-5289-4958-91c9-035746950c04?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": "Koncentrat i rozpuszczalnik do sporządzania roztworu do infuzji",
  "source": "urpl",
  "strength": "150 mg",
  "packaging": "Rp ¦ EU/1/20/1457/001 ¦ 137373\n2 fiol.",
  "substance": "Lefamulinum 150 mg",
  "common_name": "Lefamulinum",
  "pl_product_id": "100440196",
  "pozwolenie_nr": null,
  "auth_procedure": "CEN",
  "authorisation_validity": null
}

See everything about lefamulin.

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.