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Poland· PL-100058858

Rovamycine

A spiramycin product containing spiramycinum, registered in Poland by The Simple Pharma Company Limited. The same ATC class is registered in 9 of our 19 countries.

ATC J01FA02

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedRovamycineATCJ01FA02REGISTER NO.PL-100058858PACKS LISTED1CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about spiramycinumAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Spiramycin is registered in 9 of 19 countries.

Countries holding a registration under ATC J01FA02 (spiramycin), 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
Search spiramycin products by name

Spiramycin · ATC J01FA02

9 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Finlandprice
  • Franceprice
  • Germany
  • Japan
  • Norwayprice
  • Polandprice
  • United Kingdom
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
Spiramycinum
Manufacturer
The Simple Pharma Company Limited
Country
Poland (PL)
ATC code
J01FA02
ATC class
Spiramycin
Defined daily dose
3 g, O
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 1

1 priced
  • gtin
    05909990098613
    16 szt.
    PLN 32.14

Regulatory notes

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

Interactions

5 interactions on record for spiramycin.

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
Check spiramycin against other medicinesHow interaction checks work

Spiramycin · interactions on record

5 records

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

Sign in to check
Mechanism and what to do, in the interaction check
Interaction register. Grades as the source publishes them.

Same medicine, other countries

Spiramycin in 9 other countries

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

All spiramycin products

Authorised across Europe · EMA

The same active substance is authorised in 11 EEA countries. Names it is sold under:

  • Belgium · Rovamycine
  • Czechia · Rovamycine
  • Germany · Rovamycine, Selectomycin
  • Spain · Rovamycine
  • France · Rovamycine, Spiramycine Biogaran
  • Italy · Rovamicina
  • Luxembourg · Rovamycine
  • Latvia · Rovamycine
  • Portugal · Rovamycine
  • Romania · Rovamycine
  • Slovakia · Rovamycine

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/43f4dbb5-e3d0-4521-90e1-f4b854dbda95
GET /v1/drugs/43f4dbb5-e3d0-4521-90e1-f4b854dbda95?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": "Tabletki powlekane",
  "source": "urpl",
  "strength": "1,5 mln j.m.",
  "packaging": "05909990098613 ¦ Rp ¦ 44015\n16 tabl.",
  "substance": "Spiramycinum 1.5 mln. j.m.",
  "common_name": "Spiramycinum",
  "pl_product_id": "100058858",
  "pozwolenie_nr": "00986",
  "auth_procedure": "NAR",
  "authorisation_validity": "Bezterminowe"
}
API referenceMCP serverPlans

See everything about spiramycin.

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.

Try it freeOpen in the console