Poland· PL-100058870
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.
Checked against URPL (Poland) on
Informational only — not a medical device.
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
Spiramycin · ATC J01FA02
9 / 19 countries
- Belgiumprice
- Czechiaprice
- Finlandprice
- Franceprice
- Germany
- Japan
- Norwayprice
- Polandprice
- United Kingdom
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- gtin0590999069211810 szt.PLN 34.73
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
Spiramycin · interactions on record
5 records
5 more interactions with mechanism and management, from a commercially licensed source.
Sign in to checkSame 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.
- FranceROVAMYCINE 1 500 000 UI, comprimé pelliculéTAMRISA ACCESS (FRANCE)
- United KingdomRovamycine 1.5million unit powder for solution for infusion vialsImported (France)
- CzechiaROVAMYCINESanofi s.r.o., Praha
- ItalyROVAMICINA*12 cpr rivestite 3.000.000 UISANOFI Srl
- GermanyRovamycineTeofarma S.R.L.
- FinlandRovamycinRhone-Poulenc Rorer A/S
- SpainROVAMYCINE 1,5 millones de UI COMPRIMIDOS RECUBIERTOS CON PELÍCULAThe Simple Pharma Company Limited
- NorwayRovamicinaSanofi
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/de4861ee-c623-45ec-b1ae-5fd4568a0de3 GET /v1/drugs/de4861ee-c623-45ec-b1ae-5fd4568a0de3?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": "3 mln j.m.",
"packaging": "05909990692118 ¦ Rp ¦ 8775\n10 tabl.",
"substance": "Spiramycinum do 1 ml",
"common_name": "Spiramycinum",
"pl_product_id": "100058870",
"pozwolenie_nr": "06921",
"auth_procedure": "NAR",
"authorisation_validity": "Bezterminowe"
}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.