Spain· ES:60536
ROZEX 7,5 MG/G GEL
A metronidazol product containing metronidazol, registered in Spain by Laboratorios Galderma S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- metronidazol
- Manufacturer
- Laboratorios Galderma S.A.
- Country
- Spain (ES)
- ATC code
- METRONIDAZOL
- ATC class
- METRONIDAZOL
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 2026
Packs & prices · 1
1 priced- cima_codigo68896030EUR 5.37
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Metronidazol in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesMetronidazoleSun Pharmaceutical Industries, Inc.
- NetherlandsMetrosa 7,5 mg/g, gelDr. August Wolff GmbH & Co. Arzneimittel
- PolandRozeticChema-Elektromet Spółdzielnia Pracy
- FinlandNidazeaLouis Widmer GmbH
- IrelandRozex 7.5 mg/g GelGalderma International
- United KingdomAcea 0.75% gelFerndale Pharmaceuticals Ltd
- SwitzerlandArilin 1000 mg, VaginalzäpfchenAlcina AG
- GermanyArilinDr. August Wolff Gmbh & Co. Kg Arzneimittel
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · Anaerobex, Metronidazol B. Braun
- Belgium · Flagyl, Metronidazole B. Braun
- Bulgaria · Aрилин, Арилин Рапид
- Cyprus · Colpocin-T, Flagymet
- Czechia · Efloran, Entizol
- Germany · Arilin, Arilin Rapid
- Denmark · Metronidazol Actavis, Metronidazol Avia Pharma
- Estonia · Arilin, Metronidazol Orifarm
- Finland · Arilin, Flagyl
- France · Flagyl, Métronidazole Arrow
- United Kingdom (Northern Ireland) · Acea, Anabact
- Greece · Colpocin-T, Emedal
- Croatia · Arilin Rapid, Efloran
- Hungary · Klion, Metronidazol Noridem
- Ireland · Flagyl, Flagyl-S
- Iceland · Flagyl, Metronidazol Actavis
- Italy · Deflamon, Flagyl
- Lithuania · Arilin, Arilin Rapid
- Luxembourg · Flagyl, Metronidazol B. Braun
- Latvia · Arilin, Arilin Rapid
- Malta · Metronidazole B. Braun, Metronidazole Remedica
- Netherlands · Flagyl, Metronidazol Aurobindo
- Norway · Flagyl, Metronidazol Actavis
- Poland · Arilin Rapid, Metronidazol Aurovitas
- Portugal · Dabenzol, Dumozol
- Romania · Metronidazol Arena, Metronidazol B Infomed Fluids
- Sweden · Flagyl, Metronidazol Actavis
- Slovenia · Efloran, Metronidazol Braun
- Slovakia · Efloran, Entizol
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/b728c334-9a35-4692-b301-5637d8116dc6 GET /v1/drugs/b728c334-9a35-4692-b301-5637d8116dc6?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\":820450800000}",
"nregistro": "60536",
"substance": "metronidazol"
}See everything about metronidazol.
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.