Ireland· IE-PA-PA22743/013/002
Rozex 7.5 mg/g Cream
A metronidazole product containing metronidazole, registered in Ireland by Galderma International. The same ATC class is registered in 14 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Metronidazole is registered in 14 of 19 countries.
Countries holding a registration under ATC D06BX01 (metronidazole), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 8 of them publish a price we can compare per daily dose
Metronidazole · ATC D06BX01
14 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Germany
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Metronidazole
- Manufacturer
- Galderma International
- Country
- Ireland (IE)
- ATC code
- D06BX01
- ATC class
- Metronidazole
- Defined daily dose
- 15 mg, T
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA22743/013/002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
11 interactions on record for metronidazole.
Graded by severity as the source publishes them — 1 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Metronidazole · interactions on record
11 records
- 1 severe
- 10 moderate
Most severe, free to view
- AmprenavirJ05AE05severe
- WarfarinB01AA03moderate
- EthanolB05XX04moderate
- RitonavirJ05AE03moderate
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Metronidazole in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesMetroCreamGalderma Laboratories, L.P.
- CzechiaROZEXGalderma International, La Défense
- PolandRozexGalderma Polska Sp. z o.o.
- United KingdomAcea 0.75% gelFerndale Pharmaceuticals Ltd
- FinlandArilinDr. August Wolff GmbH & Co. KG Arzneimittel
- SwitzerlandArilin 1000 mg, VaginalzäpfchenAlcina AG
- GermanyArilinDr. August Wolff Gmbh & Co. Kg Arzneimittel
- FranceFLAGYL 0,5 POUR CENT, solution injectable pour perfusion en pocheSANOFI AVENTIS FRANCE
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
- Spain · Flagyl, Intizol Vaginal
- 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
- 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 HPRA (Ireland). 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/d6ff6a44-1645-4ea4-985f-116bed432292 GET /v1/drugs/d6ff6a44-1645-4ea4-985f-116bed432292?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.
{
"form": "Cream",
"routes": [
"Topical"
],
"source": "hpra",
"atc_all": [
"D06BX",
"D06BX01"
],
"strength": null,
"pa_number": "PA22743/013/002",
"substances": [
"Metronidazole"
],
"legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)",
"market_info": "Not marketed",
"authorised_at": "06/03/1998",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about metronidazole.
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.