Ireland· IE-PA-EU/1/14/986/001
Xydalba
A dalbavancin product containing dalbavancin hcl, registered in Ireland by AbbVie Deutschland GmbH & Co. KG. The same ATC class is registered in 16 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Dalbavancin is registered in 16 of 19 countries.
Countries holding a registration under ATC J01XA04 (dalbavancin), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 9 of them publish a price we can compare per daily dose
Dalbavancin · ATC J01XA04
16 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Germany
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Spainprice
- Sweden
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Dalbavancin hcl
- Manufacturer
- AbbVie Deutschland GmbH & Co. KG
- Country
- Ireland (IE)
- ATC code
- J01XA04
- ATC class
- Dalbavancin
- Defined daily dose
- 1.5 g, P
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/14/986/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
7 interactions on record for dalbavancin.
Graded by severity as the source publishes them — 7 moderate. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Dalbavancin · interactions on record
7 records
- 7 moderate
Most severe, free to view
- Sodium picosulfateA06AB08moderate
- Levonorgestrel and ethinylestradiolG03AA07moderate
- Desogestrel and ethinylestradiolG03AA09moderate
- Drospirenone and ethinylestradiolG03AA12moderate
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Dalbavancin in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SpainDALBAVANCINA ACCORD 500 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFGAccord Healthcare S.L.U.
- SwedenDalbavancin Accord 500 mg Pulver till koncentrat till infusionsvätska, lösningAccord Healthcare B.V.
- FranceDALBAVANCINE ACCORD 500 mg, poudre pour solution à diluer pour perfusionACCORD HEALTHCARE FRANCE
- United KingdomDalbavancin 500mg powder for concentrate for solution for infusion vialsAccord-UK Ltd
- GermanyDalbavancin AccordAccord Healthcare B.V.
- PolandDalbavancin AccordAccord Healthcare Polska Sp. z o.o.
- NetherlandsDalbavancine Baxter 500 mg poeder voor concentraat voor oplossing voor infusieBaxter B.V.
- CanadaXYDALBAENDO OPERATIONS LTD.
Authorised across Europe · EMA
The same active substance is authorised in 17 EEA countries. Names it is sold under:
- Austria · Dalbavancin, Dalbavancin Accord
- Germany · Dalbavancin Accord, Dalbavancin Baxter
- Denmark · Dalbavancin Adalvo, Dalbavancin Teva
- Spain · Dalbavancin Dr. Reddys, Dalbavancina Accord
- Finland · Dalbavancin Adalvo, Dalbavancin Tillomed
- France · Dalbavancine Accord, Dalbavancine Reddy Pharma
- United Kingdom (Northern Ireland) · Dalbavancin Accord, Dalbavancin Reig Jofre Uk
- Greece · Bavalda, Dalbavancin Accord
- Iceland · Xydalba
- Italy · Dalbavancina Accord, Dalbavancina Dr. Reddy’s
- Liechtenstein · Xydalba
- Malta · Bavalda, Dalbavancin Adalvo
- Norway · Dalbavancin Tillomed, Xydalba
- Poland · Dalbavancin Accord, Dalbavancin Reig Jofre
- Portugal · Dalbavancina Anfarm
- Sweden · Dalbavancin Accord, Dalbavancin Bioglan
- Slovakia · Dalbavancin Adalvo
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 HPRA (Ireland). 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/05aa50bc-c625-4750-b4d4-b7ebda14e1b8 GET /v1/drugs/05aa50bc-c625-4750-b4d4-b7ebda14e1b8?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": "Powder for concentrate for solution for infusion",
"routes": [
"Intravenous use"
],
"source": "hpra",
"atc_all": [
"J01XA",
"J01XA04"
],
"strength": null,
"pa_number": "EU/1/14/986/001",
"substances": [
"Dalbavancin hcl"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "19/02/2015",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about dalbavancin.
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.