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Belgium· BE-AMP-SAM664003-00

Dalbavancine Baxter 500 mg

A dalbavancin product containing dalbavancin hydrochloride, registered in Belgium by Baxter Holding. The same ATC class is registered in 16 of our 19 countries.

ATC J01XA04

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedDalbavancine Baxter 500 mgATCJ01XA04REGISTER NO.BE-AMP-SAM664003-00PACKS LISTED0CHECKEDSeptember 26, 2026

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: Belgium, from FAMHP / AFMPS (Belgium)
  • 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
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Dalbavancin Hydrochloride
Manufacturer
Baxter Holding
Country
Belgium (BE)
ATC code
J01XA04
ATC class
Dalbavancin
Defined daily dose
1.5 g, P
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 0

No packs listed by the register for this record.

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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Dalbavancin in 4 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All dalbavancin products

Authorised across Europe · EMA

The same active substance is authorised in 11 EEA countries. Names it is sold under:

  • Austria · Dalbavancin, Dalbavancin Newbury
  • Denmark · Dalbavancin Baxter
  • Spain · Dalbavancina Baxter
  • Finland · Dalbavancin Baxter
  • France · Dalbavancine
  • United Kingdom (Northern Ireland) · Dalbavancin Baxter, Dalbavancin Teva
  • Italy · Dalbavancina
  • Luxembourg · Dalbavancin, Dalbavancine
  • Netherlands · Dalbavancine Baxter
  • Norway · Dalbavancin
  • Sweden · Dalbavancin

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 FAMHP / AFMPS (Belgium). 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/f24e982d-14d6-4cc0-80ef-dde0d45f0405
GET /v1/drugs/f24e982d-14d6-4cc0-80ef-dde0d45f0405?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",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Dalbavancine Baxter 500 mg",
  "name_fr": "Dalbavancine Baxter 500 mg",
  "name_nl": "Dalbavancine Baxter 500 mg",
  "amp_code": "SAM664003-00",
  "strengths": [
    "516.0000",
    "516.0000",
    "500.0000",
    "500.0000",
    "126.5000",
    "126.5000"
  ],
  "pack_count": 1,
  "substances": [
    "Dalbavancin Hydrochloride",
    "Dalbavancin",
    "Mannitol",
    "Lactose Monohydrate",
    "Sodium Hydroxide"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Dalbavancin",
  "authorisation_numbers": [
    "BE664003"
  ]
}

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.