Spain· ES:65554
AZITROMICINA BENEL 500 mg POLVO PARA SUSPENSION ORAL EN SOBRE EFG
A medicinal product containing azitromicina, registered in Spain by Dermogen-Farma S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- azitromicina
- Manufacturer
- Dermogen-Farma 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
Azitromicina in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomAzithromycin 200mg/5ml oral suspensionMawdsley-Brooks & Company Ltd
- PolandAzibiotKrka, d.d., Novo mesto
- ItalyAZACIDGENETIC S.P.A.
- SwitzerlandAzithrolag 250 mg, compresse rivestite con filmLagap SA
- CanadaAG-AZITHROMYCINANGITA PHARMA INC.
- FranceAZADOSE 600 mg, comprimé pelliculéPFIZER HOLDING FRANCE
- NetherlandsAzitromycine 200 mg/5 ml Teva, poeder voor orale suspensieTeva Nederland B.V.
- SwedenAmzolynic 500 mg Pulver till koncentrat till infusionsvätska, lösningMACURE PHARMA ApS
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · Azithromycin +pharma, Azithromycin 1a Pharma
- Belgium · Azithromycin Ab, Azithromycine Eg
- Bulgaria · Azax, Азакс
- Cyprus · Azithran, Azithromycin Altan Pharmaceuticals, S.A.
- Czechia · Azitromycin Sandoz, Azitromycin Viatris
- Germany · Azi-Teva, Azithromycin 500
- Denmark · Amzolynic, Azithromycin "sandoz"
- Estonia · Azithromycin Krka, Azithromycin Sandoz
- Finland · Amzolynic, Azithromycin Krka
- France · Azithromycine Bgr, Azithromycine Bluepharma
- United Kingdom (Northern Ireland) · Azithromycin, Azithromycin Accord-Uk
- Greece · Alzirax, Azibactron
- Croatia · Azibiot, Azimed
- Hungary · Azi, Azibactim
- Ireland · Azithromycin Clonmel, Azithromycin Krka
- Iceland · Azithromycin Stada, Azitromicina Normon
- Italy · Azeptin, Azitromicina Altan Pharmaceuticals, S.A.
- Lithuania · Azibiot, Azithromycin Ingen Pharma
- Luxembourg · Azithromycin Ratiopharm, Azithromycine Eg
- Latvia · Azibiot, Azithromycin Sandoz
- Malta · Azimycin, Azithromycin Aurobindo
- Netherlands · Azithromycine Ratiopharm, Azithromycine Teva
- Norway · Amzolynic
- Poland · Azibiot, Azimycin
- Portugal · Azitrix, Azitromicina Almus
- Romania · Azibiot, Azitromicină Rompharm
- Sweden · Amzolynic, Azithromycin Jubilant
- Slovenia · Azibiot, Azitromicin Krka
- Slovakia · Azibiot, Azibiot Neo
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/a0dc0d77-4116-4c6b-9e8a-52d10f0a1dee GET /v1/drugs/a0dc0d77-4116-4c6b-9e8a-52d10f0a1dee?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\":1062972000000,\"rev\":1747146612000}",
"nregistro": "65554",
"substance": "azitromicina"
}See everything about azitromicina.
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.