Spain· ES:91583
FIDAXOMICINA SUN 200 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA
A medicinal product containing fidaxomicina, registered in Spain by Sun Pharmaceutical Industries (Europe) B.V..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- fidaxomicina
- Manufacturer
- Sun Pharmaceutical Industries (Europe) B.V.
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- August 31, 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
Fidaxomicina in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesDificidMerck Sharp & Dohme LLC
- CzechiaDIFICLIRTillotts Pharma GmbH, Rheinfelden
- SwedenDIFICLIR 200 mg Filmdragerad tablettTillotts Pharma GmbH
- FinlandDificlirTillotts Pharma GmbH
- FranceDIFICLIR 200 mg, comprimé pelliculéTILLOTTS PHARMA (ALLEMAGNE)
- BelgiumDificlir 200 mgTillotts Pharma
- IcelandDificlirTillotts Pharma GmbH
- NetherlandsDificlir, 200mg, filmomhulde tablettenTillotts Pharma GmbH
Authorised across Europe · EMA
The same active substance is authorised in 6 EEA countries. Names it is sold under:
- France · Fidaxomicine Sun
- United Kingdom (Northern Ireland) · Fidaxomicin Tillotts 200 Mg, Fidaxomicin Tillotts 40 Mg/Ml
- Iceland · Dificlir
- Liechtenstein · Dificlir, Dificlir 200 Mg
- Norway · Dificlir, Dificlir 200 Mg
- Sweden · Fidaxomicin Sun
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 AEMPS CIMA (Spain). 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/a31f754f-66eb-4538-ac15-65973c993708 GET /v1/drugs/a31f754f-66eb-4538-ac15-65973c993708?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.
{
"cpresc": "Medicamento Sujeto A Prescripción Médica",
"estado": "{\"aut\":1787932323000}",
"nregistro": "91583",
"substance": "fidaxomicina"
}See everything about fidaxomicina.
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.