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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.

SOURCE REGISTER · ESAEMPS CIMA (Spain)normalisedFOSFOMICINA LEVEL INTRAMUSCULAR 1 g P…ATC—REGISTER NO.ES:54164PACKS LISTED0CHECKEDSeptember 12, 2026

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.

All fosfomicina products

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.