Ireland· IE-PA-PA22650/003/001
Pivmecillinam hydrochloride Karo Pharma 400 mg film-coated tablets
A pivmecillinam product containing pivmecillinam hydrochloride, registered in Ireland by Karo Pharma AB. The same ATC class is registered in 12 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Pivmecillinam is registered in 12 of 19 countries.
Countries holding a registration under ATC J01CA08 (pivmecillinam), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 7 of them publish a price we can compare per daily dose
Pivmecillinam · ATC J01CA08
12 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Germany
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Pivmecillinam hydrochloride
- Manufacturer
- Karo Pharma AB
- Country
- Ireland (IE)
- ATC code
- J01CA08
- ATC class
- Pivmecillinam
- Defined daily dose
- 0.6 g, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA22650/003/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Pivmecillinam in 7 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaPIVINORMHerbacos Recordati s.r.o., Pardubice
- FinlandPenomaxOrion Corporation
- SwedenPenomax 400 mg Filmdragerad tablettOrion Corporation
- BelgiumSelexid 400 mgKaro Healthcare
- NorwayPenomaxOrion Corporation Orion Pharma, Espoo
- GermanyPivmelamApogepha Arzneimittel Gmbh
- United StatesPIVYAAlembic Pharmaceuticals Inc.
Authorised across Europe · EMA
The same active substance is authorised in 18 EEA countries. Names it is sold under:
- Austria · Selexid
- Belgium · Selexid
- Czechia · Pivinorm
- Germany · Pivmelam, X-Systo
- Denmark · Penomax, Pivmecillinamhydrochlorid Karo Pharma
- Spain · Selexid
- Finland · Penomax, Selexid
- France · Selexid
- United Kingdom (Northern Ireland) · Pivmecillinam Hydrochloride Milpharm, Selexid
- Greece · Selexid
- Iceland · Penomax, Selexid
- Italy · Xsysto
- Luxembourg · Selexid
- Netherlands · Selexid
- Norway · Penomax, Selexid
- Poland · X-Systo
- Portugal · Pivmecilinam Aurobindo
- Sweden · Penomax, Selexid
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/2ed9bcb3-133b-4830-867b-38359cb1e3e6 GET /v1/drugs/2ed9bcb3-133b-4830-867b-38359cb1e3e6?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": "Film-coated tablet",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"J01CA",
"J01CA08"
],
"strength": null,
"pa_number": "PA22650/003/001",
"substances": [
"Pivmecillinam hydrochloride"
],
"legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)",
"market_info": "Not marketed",
"authorised_at": "02/12/2016",
"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 pivmecillinam.
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.