Poland· PL-100512878
Kavigale
A antiviral monoclonal antibodies product containing sipavibart, registered in Poland by AstraZeneca AB.
Checked against URPL (Poland) on
Informational only — not a medical device.
The record
At a glance
URPL (Poland)- Active substance
- Sipavibart
- Manufacturer
- AstraZeneca AB
- Country
- Poland (PL)
- ATC code
- J06BD
- ATC class
- Antiviral monoclonal antibodies
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 1
- gtin05000456087544
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sipavibart in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumKavigale 300 mgAstraZeneca
- CzechiaKAVIGALEAstraZeneca AB, Södertälje
- SpainKAVIGALE 300 MG SOLUCION INYECTABLE Y PARA PERFUSIONAstrazeneca Ab
- FinlandKAVIGALEAstraZeneca AB
- IcelandKavigaleAstraZeneca AB
- SwedenKAVIGALE 300 mg Injektions-/infusionsvätska, lösningAstraZeneca AB
- IrelandKAVIGALE 300 mg solution for injection/infusionAstraZeneca AB
- NetherlandsKAVIGALE 300 mg oplossing voor injectie/infusieAstraZeneca AB
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Kavigale
- Liechtenstein · Kavigale
- Norway · Kavigale
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/019a6ad7-cd71-496b-89d7-f5ce1c5282c5 GET /v1/drugs/019a6ad7-cd71-496b-89d7-f5ce1c5282c5?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": "Roztwór do wstrzykiwań / do infuzji",
"source": "urpl",
"strength": "300 mg",
"packaging": "05000456087544 ¦ Rp ¦ EU/1/24/1900/001 ¦ 160383\n1 fiol. 2 ml",
"substance": "Sipavibart 300 mg",
"common_name": "Sipavibart",
"pl_product_id": "100512878",
"pozwolenie_nr": null,
"auth_procedure": "CEN",
"authorisation_validity": null
}See everything about sipavibart.
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.