Germany· DE-A57-531dbe3867522ce7
Gutivia
A medicinal product containing rifamycin sodium, registered in Germany by Lunatus Gmbh.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Rifamycin Sodium
- Manufacturer
- Lunatus Gmbh
- Country
- Germany (DE)
- ATC code
- —
- 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.
Same medicine, other countries
Rifamycin sodium in 7 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FranceOTOFA, solution auriculaire en gouttesBOUCHARA-RECORDATI
- ItalyDOTECINE*12 cpr 200 mg rilascio modificatoMALESCI SpA IST.FARMACOBIOL.
- SpainRIFAMICINA ADALVO 200 MG COMPRIMIDOS DE LIBERACION MODIFICADAAdalvo Competence Center S.R.L.
- FinlandRelafalkAdalvo Competence Center S.R.L.
- BelgiumRifocine 500 IV 500 mgSanofi Belgium
- PolandRifamycin AdalvoAdalvo Competence Center S.R.L.
- SwedenRifamycin Adalvo 200 mg Tablett med modifierad frisättningAdalvo Limited
Authorised across Europe · EMA
The same active substance is authorised in 12 EEA countries. Names it is sold under:
- Belgium · Rifocine I.V.
- Bulgaria · Relafalk
- Finland · Relafalk
- France · Otofa, Rifamycine Chibret
- Greece · Relafalk
- Hungary · Relafalk
- Italy · Dotecine, Rifocin
- Luxembourg · Otofa, Rifocine I.V.
- Norway · Relafalk
- Poland · Relafalk
- Portugal · Imfalda, Rifocina
- Sweden · Relafalk
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/05c796cc-48ac-4a42-86f7-776b6b398d70 GET /v1/drugs/05c796cc-48ac-4a42-86f7-776b6b398d70?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": "Rifamycin Sodium",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about rifamycin sodium.
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.