Poland· PL-100460685

Gavreto

A pralsetinib product containing pralsetinibum, registered in Poland by Roche Registration GmbH. The same ATC class is registered in 8 of our 19 countries.

ATC L01EX23

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedGavretoATCL01EX23REGISTER NO.PL-100460685PACKS LISTED5CHECKEDSeptember 27, 2026

Where it is registered

Pralsetinib is registered in 8 of 19 countries.

Countries holding a registration under ATC L01EX23 (pralsetinib), 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

Pralsetinib · ATC L01EX23

8 / 19 countries

  • Belgiumprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Norwayprice
  • Polandprice
  • 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.

The record

At a glance

URPL (Poland)
Active substance
Pralsetinibum
Manufacturer
Roche Registration GmbH
Country
Poland (PL)
ATC code
L01EX23
ATC class
Pralsetinib
Defined daily dose
0.4 g, O
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 5

  • gtin
    07613326044813
  • gtin
    07613326044806
  • gtin
    04150171951666
  • gtin
    07613326044776
  • gtin
    07613326044820

Regulatory notes

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

Interactions

93 interactions on record for pralsetinib.

Graded by severity as the source publishes them — 16 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

Pralsetinib · interactions on record

93 records

  • 16 severe
  • 77 moderate

Most severe, free to view

  • KetoconazoleH02CA03severe
  • ClarithromycinJ01FA09severe
  • KetoconazoleJ02AB02severe
  • Darunavir and cobicistatJ05AR14severe
  • 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.

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/9d102960-b327-4295-afc3-3e15ec165e17
GET /v1/drugs/9d102960-b327-4295-afc3-3e15ec165e17?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": "Kapsułki twarde",
  "source": "urpl",
  "strength": "100 mg",
  "packaging": "07613326044813 ¦ Rpz ¦ EU/1/21/1555/001 ¦ 142558\n60 kaps.\n07613326044806 ¦ Rpz ¦ EU/1/21/1555/003 ¦ 142559\n120 kaps.\n¦ UR/Z/4c/087/22 - 04150171951666 ¦ UR/Z/4c/152/22 - 07613326044776 ¦ UR/Z/4c/164/22 - 07613326044776\n07613326044820 ¦ Rpz ¦ EU/1/21/1555/002 ¦ 142560\n90 kaps.",
  "substance": "Pralsetinibum 100 mg",
  "common_name": "Pralsetinibum",
  "pl_product_id": "100460685",
  "pozwolenie_nr": null,
  "auth_procedure": "CEN",
  "authorisation_validity": "2024-10-24"
}

See everything about pralsetinib.

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.