Germany· DE-A57-ee39e1a40612ddbf
Rovamycine
A spiramycin product containing spiramycin, registered in Germany by Teofarma S.R.L.. The same ATC class is registered in 9 of our 19 countries.
Checked against EMA Article 57 (European Union) 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: Germany, from EMA Article 57 (European Union)
- 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
EMA Article 57 (European Union)- Active substance
- Spiramycin
- Manufacturer
- Teofarma S.R.L.
- Country
- Germany (DE)
- ATC code
- J01FA02
- ATC class
- Spiramycin
- Defined daily dose
- 3 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
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)
- CzechiaROVAMYCINESanofi s.r.o., Praha
- United KingdomRovamycine 1.5million unit powder for solution for infusion vialsImported (France)
- PolandRovamycineThe Simple Pharma Company Limited
- FinlandRovamycinRhone-Poulenc Rorer A/S
- ItalyROVAMICINA*12 cpr rivestite 3.000.000 UISANOFI Srl
- BelgiumRovamycine 1500000 IUThe Simple Pharma Company
- NorwayRovamicinaSanofi
Authorised across Europe · EMA
The same active substance is authorised in 11 EEA countries. Names it is sold under:
- Belgium · Rovamycine
- Czechia · Rovamycine
- Spain · Rovamycine
- France · Rovamycine, Spiramycine Biogaran
- Italy · Rovamicina
- Luxembourg · Rovamycine
- Latvia · Rovamycine
- Poland · 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 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/0f42545c-9265-4d31-9e12-67abe72b192b GET /v1/drugs/0f42545c-9265-4d31-9e12-67abe72b192b?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": "Spiramycin",
"atc_from_source": null,
"authorisation_country": "Germany"
}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.