Spain· ES:54164
FOSFOMICINA LEVEL INTRAMUSCULAR 1 g POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
A medicinal product containing fosfomicina, registered in Spain by Laboratorios Ern S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- fosfomicina
- Manufacturer
- Laboratorios Ern S.A.
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 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
Fosfomicina in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomAlexi 3g granules for oral solution sachetsNordic Pharma Ltd
- FranceFOMICYT 2 g I.V., poudre pour solution à diluer pour perfusionINFECTOPHARM ARZNEIMITTEL UND CONSILIUM (ALLEMAGNE)
- ItalyBERNYFIDIA SPECIALTY S.R.L.
- PolandAfasturalExeltis Poland Sp. z o.o.
- United StatesContepoMeitheal Pharmaceuticals Inc.
- GermanyAfosfolAxunio Pharma Gmbh
- CzechiaFOMICYTInfectopharm Arzneimittel und Consilium GmbH, Heppenheim
- BelgiumFomicyt 40 mg/mlInfectoPharm Arzneimittel und Consilium
Authorised across Europe · EMA
The same active substance is authorised in 28 EEA countries. Names it is sold under:
- Austria · Cystium, Fomicyt
- Belgium · Fomicyt, Fosfomycin Ab
- Bulgaria · Монурал, Фосфосептик
- Czechia · Fomicyt, Rapidnorm
- Germany · Afosfol, Fosfomycin Al
- Denmark · Fosfomycin Infectopharm, Monurol
- Estonia · Fosfomycin Sandoz, Uridoz
- Finland · Fosfomycin Infectopharm, Monuril
- France · Fomicyt I.V., Fosfomycine Adultes Cristers
- United Kingdom (Northern Ireland) · Alexi, Fomicyt
- Greece · Fomicyt, Fosfocin
- Croatia · Fomicyt, Urifos
- Hungary · Afosfol, Fomicyt
- Ireland · Fomicyt, Fosfomycin Ascend
- Iceland · Monuril
- Italy · Berny Adulti, Dafocist Adulti
- Lithuania · Fosfomycin Zentiva, Foziflum
- Luxembourg · Monuril
- Latvia · Foziflum, Rebetyn Vigapharma
- Malta · Monuril
- Netherlands · Fomicyt, Fosfomycine 1a Pharma
- Norway · Fosfomycin Infectopharm, Monuril
- Poland · Afastural, Fosfacin
- Portugal · Fosfomicina Generis, Fosfomicina Generis Phar
- Romania · Fomicyt, Fosfomicină Rompharm
- Sweden · Fosfomycin Infectopharm, Monuril
- Slovenia · Cisof
- Slovakia · Fomicyt, Fosfomed
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/df15bf64-28ed-499e-8e28-04ed8a8cecd9 GET /v1/drugs/df15bf64-28ed-499e-8e28-04ed8a8cecd9?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": "Diagnóstico Hospitalario",
"estado": "{\"aut\":257554800000,\"rev\":1705928635000}",
"nregistro": "54164",
"substance": "fosfomicina"
}See everything about fosfomicina.
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.