Germany· DE-A57-ef24c71c34a72366
X-Systo
A pivmecillinam product containing pivmecillinam hydrochloride, registered in Germany by Karo Pharma Ab. The same ATC class is registered in 12 of our 19 countries.
Checked against EMA Article 57 (European Union) 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: Germany, from EMA Article 57 (European Union)
- 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
EMA Article 57 (European Union)- Active substance
- Pivmecillinam Hydrochloride
- Manufacturer
- Karo Pharma Ab
- Country
- Germany (DE)
- ATC code
- J01CA08
- ATC class
- Pivmecillinam
- Defined daily dose
- 0.6 g, O
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 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
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 200 mg Filmdragerad tablettOrion Corporation
- NorwayPenomaxOrion Corporation Orion Pharma, Espoo
- United StatesPIVYAAlembic Pharmaceuticals Inc.
- IrelandPivmecillinam hydrochloride Karo Pharma 400 mg film-coated tabletsKaro Pharma AB
- BelgiumSelexid 400 mgKaro Healthcare
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
- Denmark · Penomax, Pivmecillinamhydrochlorid Karo Pharma
- Spain · Selexid
- Finland · Penomax, Selexid
- France · Selexid
- United Kingdom (Northern Ireland) · Pivmecillinam Hydrochloride Milpharm, Selexid
- Greece · Selexid
- Ireland · Pivmecillinam Hydrochloride Karo Pharma
- 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 EMA Article 57 (European Union). 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/d87f0259-f61f-4b6a-a950-ec2abc0776df GET /v1/drugs/d87f0259-f61f-4b6a-a950-ec2abc0776df?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.
{
"pzn": null,
"route": "Oral Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Pivmecillinam Hydrochloride",
"atc_from_source": null,
"authorisation_country": "Germany"
}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.