Poland· PL-100114189
Replagal
A agalsidase alfa product containing agalsidasum, registered in Poland by Takeda Pharmaceuticals International AG Ireland Branch. The same ATC class is registered in 13 of our 19 countries.
Checked against URPL (Poland) on
Informational only — not a medical device.
Where it is registered
Agalsidase alfa is registered in 13 of 19 countries.
Countries holding a registration under ATC A16AB03 (agalsidase alfa), 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
Agalsidase alfa · ATC A16AB03
13 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
The record
At a glance
URPL (Poland)- Active substance
- Agalsidasum
- Manufacturer
- Takeda Pharmaceuticals International AG Ireland Branch
- Country
- Poland (PL)
- ATC code
- A16AB03
- ATC class
- Agalsidase alfa
- Defined daily dose
- 1 mg, P
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 6
- gtin05909990999514
- gtin05909990999521
- gtin05909990999538
- gtin05909990053773
- gtin05909990053780
- gtin05909990053797
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same class
Other records under A16AB03
Agalsidase alfa, as other registers publish it.
- FinlandReplagalTakeda Pharmaceuticals International AG Ireland Branch
- FinlandReplagalOrifarm Oy
- IcelandReplagalTakeda Pharmaceuticals International AG Ireland Branch
- NorwayReplagalTakeda Pharmaceuticals International AG Ireland Branch
- DenmarkReplagalTakeda Pharmaceuticals International AG Ireland Branch
- CanadaREPLAGALTAKEDA CANADA INC
- CzechiaREPLAGALTakeda Pharmaceuticals International AG Ireland Branch, Dublin
- CzechiaREPLAGALTakeda Pharmaceuticals International AG Ireland Branch, Dublin
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/28a79a7a-0c4d-4ad9-ac25-a8ea09d474e8 GET /v1/drugs/28a79a7a-0c4d-4ad9-ac25-a8ea09d474e8?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": "Koncentrat do sporządzania roztworu do infuzji",
"source": "urpl",
"strength": "1 mg/ml",
"packaging": "05909990999514 ¦ Rpz ¦ EU/1/01/189/001 ¦ 20740\n1 fiol. 3,5 ml\n05909990999521 ¦ Rpz ¦ EU/1/01/189/002 ¦ 20741\n4 fiol. 3,5 ml\n05909990999538 ¦ Rpz ¦ EU/1/01/189/003 ¦ 20742\n10 fiol. 3,5 ml\n05909990053773 ¦ Rp ¦ Skasowane ¦ EU/1/01/189/004 ¦ 36300\n1 fiol. 1 ml\n05909990053780 ¦ Rp ¦ Skasowane ¦ EU/1/01/189/005 ¦ 36301\n4 fiol. 1 ml\n05909990053797 ¦ Rp ¦ Skasowane ¦ EU/1/01/189/006 ¦ 36302\n10 fiol. 1 ml",
"substance": "Agalsidasum alfa 1 mg",
"common_name": "Agalsidasum",
"pl_product_id": "100114189",
"pozwolenie_nr": null,
"auth_procedure": "CEN",
"authorisation_validity": null
}See everything about agalsidase alfa.
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.