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Ireland· IE-PA-PA2004/008/001

Cuvitru 200 mg/ml solution for subcutaneous injection

A humane immunglobuline, unspezifisch, extravaskulär product containing human normal immunoglobulin, registered in Ireland by Baxalta Innovations GmbH. The same ATC class is registered in 11 of our 19 countries.

ATC J06BA01

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedCuvitru 200 mg/ml solution for subcut…ATCJ06BA01REGISTER NO.IE-PA-PA2004/008/001PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Humane immunglobuline, unspezifisch, extravaskulär is registered in 11 of 19 countries.

Countries holding a registration under ATC J06BA01 (humane immunglobuline, unspezifisch, extravaskulär), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 7 of them publish a price we can compare per daily dose

Humane immunglobuline, unspezifisch, extravaskulär · ATC J06BA01

11 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
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

HPRA (Ireland)
Active substance
Human normal immunoglobulin
Manufacturer
Baxalta Innovations GmbH
Country
Ireland (IE)
ATC code
J06BA01
ATC class
Humane Immunglobuline, unspezifisch, extravaskulär
Defined daily dose
1.4 g, P
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PA2004/008/001

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

48 interactions on record for humane immunglobuline, unspezifisch, extravaskulär.

Graded by severity as the source publishes them — 44 severe. 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

Humane immunglobuline, unspezifisch, extravaskulär · interactions on record

48 records

  • 44 severe
  • 4 minor

Most severe, free to view

  • NeomycinA07AA01severe
  • StreptomycinA07AA04severe
  • Polymyxin BA07AA05severe
  • Amphotericin BA07AA07severe
  • 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

Humane immunglobuline, unspezifisch, extravaskulär in 12 other countries

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

All humane immunglobuline, unspezifisch, extravaskulär products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Cutaquig, Cuvitru
  • Belgium · Cutaquig, Cuvitru
  • Bulgaria · Имуновенин, Интратект
  • Cyprus · Gamunex, Intratect
  • Czechia · Cutaquig, Cuvitru
  • Germany · Beriglobin, Cutaquig
  • Denmark · Cutaquig, Cuvitru
  • Estonia · Cutaquig, Gammanorm
  • Spain · Cutaquig, Cuvitru
  • Finland · Cutaquig, Cuvitru
  • France · Clairyg, Cutaquig
  • United Kingdom (Northern Ireland) · Cutaquig, Cuvitru
  • Greece · Gaminex, Ig Vena
  • Croatia · Cutaquig, Ig Vena
  • Hungary · Cutaquig, Gammanorm
  • Iceland · Cutaquig, Deqsiga
  • Italy · Cutaquig, Cuvitru
  • Liechtenstein · Deqsiga, Flebogamma Dif
  • Lithuania · Cutaquig, Gammanorm
  • Luxembourg · Cutaquig, Gammagard S/D (Solvent/Detergent)
  • Latvia · Cutaquig, Gammanorm
  • Malta · Cutaquig, Gammanorm
  • Netherlands · Cutaquig, Cuvitru
  • Norway · Cutaquig, Cuvitru
  • Poland · Cutaquig, Cuvitru
  • Portugal · Cutaquig, Gammanorm
  • Romania · Cutaquig, Gammanorm
  • Sweden · Cutaquig, Cuvitru
  • Slovenia · Cutaquig, Gammanorm
  • Slovakia · Cutaquig, Cuvitru

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/d45dc196-dcef-4253-b79a-2299266372ed
GET /v1/drugs/d45dc196-dcef-4253-b79a-2299266372ed?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": "Solvent for...",
  "routes": [
    "Subcutaneous use"
  ],
  "source": "hpra",
  "atc_all": [
    "J06BA01"
  ],
  "strength": null,
  "pa_number": "PA2004/008/001",
  "substances": [
    "Human normal immunoglobulin"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Marketed",
  "authorised_at": "08/07/2016",
  "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 humane immunglobuline, unspezifisch, extravaskulär.

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.