Poland· PL-100112026
Ferrum Lek
A ferric hydroxide product containing ferri hydroxidum polymaltosum, registered in Poland by Sandoz GmbH.
Checked against URPL (Poland) on
Informational only — not a medical device.
The record
At a glance
URPL (Poland)- Active substance
- Ferri hydroxidum polymaltosum
- Manufacturer
- Sandoz GmbH
- Country
- Poland (PL)
- ATC code
- B03AB04
- ATC class
- Ferric hydroxide
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 1
- gtin05909990976416
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ferric hydroxide in 5 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandMaltoferOrifarm Oy
- CzechiaMALTOFERVifor France, Paris
- BelgiumHemafer 100 mgUni-Pharma Kleon Tsetis Pharmaceutical Laboratories
- SpainFEROFIX 100 MG COMPRIMIDOS MASTICABLESUni-Pharma Kleon Tsetis Pharmaceutical Laboratories, S.A.
- ItalyINTRAFER*orale gtt 30 ml 50 mg/mlPHARMADAY PHARM.Srl UNIPERSONA
Authorised across Europe · EMA
The same active substance is authorised in 6 EEA countries. Names it is sold under:
- Bulgaria · Айронлек Адифарм
- Czechia · Maltofer
- Greece · Dextrifer, Feralice
- Hungary · Maltofer
- Italy · Intrafer
- Romania · Ferrum Hausmann, Maltofer
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/a84025f5-d86b-4dbf-ae38-e2658d0e3935 GET /v1/drugs/a84025f5-d86b-4dbf-ae38-e2658d0e3935?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": "Tabletki do rozgryzania i żucia",
"source": "urpl",
"strength": "100 mg Fe3+",
"packaging": "05909990976416 ¦ Rp ¦ 46899\n30 tabl.",
"substance": "Ferri hydroxydum polymaltosum 100 mg",
"common_name": "Ferri hydroxidum polymaltosum",
"pl_product_id": "100112026",
"pozwolenie_nr": "09764",
"auth_procedure": "NAR",
"authorisation_validity": "Bezterminowe"
}See everything about ferric hydroxide.
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.