Poland· PL-100317515
Nizax Activ
A ketoconazole product containing ketoconazolum, registered in Poland by Przedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A.. The same ATC class is registered in 14 of our 19 countries.
Checked against URPL (Poland) on
Informational only — not a medical device.
Where it is registered
Ketoconazole is registered in 14 of 19 countries.
Countries holding a registration under ATC D01AC08 (ketoconazole), each read from that country’s own register.
- This record: Poland, from URPL (Poland)
- 8 of them publish a price we can compare per daily dose
Ketoconazole · ATC D01AC08
14 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Germany
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
URPL (Poland)- Active substance
- Ketoconazolum
- Manufacturer
- Przedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A.
- Country
- Poland (PL)
- ATC code
- D01AC08
- ATC class
- Ketoconazole
- Defined daily dose
- 30 mg, T
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 2
- gtin05909991141370
- gtin05909991141387
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ketoconazole in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- IrelandKetoconazole 20mg/g ShampooPinewood Laboratories Limited
- NetherlandsKetoconazol Aurobindo Shampoo 20 mg/g, shampooAurobindo Pharma B.V.
- FinlandKetokonazol Oriola-KDPinewood Laboratories Limited
- SwedenKetoconazol Actavis 20 mg/g SchampoActavis Group PTC ehf.
- United States1% ketoconazoleTAGRID LLC
- United KingdomBoots Anti-Dandruff 2% shampooThe Boots Company Plc
- FranceKETOCONAZOLE ARROW 2 %, gel en récipient-unidoseARROW GENERIQUES
- SpainFUNGAREST 20 mg/g cremaLaboratorio Stada S.L.
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Fungoral, Nizoral
- Belgium · Nizoral
- Bulgaria · Ketoderm, Nizoral
- Cyprus · Ilgem Med, Nizoral
- Czechia · Ketokonazol Dr.Max, Nizoral
- Germany · Ketoconazol Klinge, Ketozolin
- Denmark · Ketoconazole Actavis, Nizoral
- Estonia · Ketoconazol Ratiopharm, Mikanisal
- Spain · Fungarest, Keto-Cure
- Finland · Ketoconazol Ratiopharm, Ketoconazole Stada
- France · Kapanek, Ketoconazole Arrow
- United Kingdom (Northern Ireland) · Daktarin Gold, Daktarin Intensiv
- Greece · Botaderm, Ebersept
- Croatia · Oronazol
- Hungary · Nizoral, Nizoral Korpásodás Ellen
- Ireland · Ketoconazole Pinewood Laboratories, Nizoral
- Iceland · Dermatín, Fungoral
- Italy · Ketonova, Nizoblue
- Liechtenstein · Ketoconazole Esteve
- Lithuania · Ketoconazol Ratiopharm, Nizoral
- Luxembourg · Nizoral
- Latvia · Ketoconazol Ratiopharm, Mikanisal
- Malta · Nizoral
- Netherlands · Ketoconazol Cf, Ketoconazol Double-E Pharma
- Norway · Fungoral, Ketoconazole Esteve
- Portugal · Cetoconazol Folicalm, Nizoral
- Romania · Ketoconazol Dr. Max, Ketoconazol Dr.Max
- Sweden · Fungoral, Ketoconazol Actavis
- Slovenia · Oronazol
- Slovakia · Ketoconazol Dr. Max, Nizoral
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 URPL (Poland). 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/e8980f23-a887-4092-8302-4e1fe16b4ce7 GET /v1/drugs/e8980f23-a887-4092-8302-4e1fe16b4ce7?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": "Szampon leczniczy",
"source": "urpl",
"strength": "20 mg/g",
"packaging": "05909991141370 ¦ OTC ¦ 91977\n1 butelka 100 ml\n05909991141387 ¦ OTC ¦ 91978\n6 sasz. 6 ml",
"substance": "Ketoconazolum 20 mg",
"common_name": "Ketoconazolum",
"pl_product_id": "100317515",
"pozwolenie_nr": "21900",
"auth_procedure": "NAR",
"authorisation_validity": "Bezterminowe"
}See everything about ketoconazole.
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.