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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.

ATC J01CA08

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedPivmecillinam hydrochloride Karo Phar…ATCJ01CA08REGISTER NO.IE-PA-PA22650/003/001PACKS LISTED1CHECKEDSeptember 28, 2026

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
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

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_number
    PA22650/003/001

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.

All pivmecillinam products

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.