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Ireland· IE-PA-PA0773/004/001

Lactulose 10 g/15 ml Oral Solution Sachets

A lactulose product containing lactulose, registered in Ireland by Fresenius Kabi Austria GmbH. The same ATC class is registered in 16 of our 19 countries.

ATC A06AD11

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedLactulose 10 g/15 ml Oral Solution Sa…ATCA06AD11REGISTER NO.IE-PA-PA0773/004/001PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Lactulose is registered in 16 of 19 countries.

Countries holding a registration under ATC A06AD11 (lactulose), each read from that country’s own register.

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

Lactulose · ATC A06AD11

16 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Sweden
  • Switzerlandprice
  • 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

HPRA (Ireland)
Active substance
Lactulose
Manufacturer
Fresenius Kabi Austria GmbH
Country
Ireland (IE)
ATC code
A06AD11
ATC class
Lactulose
Defined daily dose
12.5 g, O
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PA0773/004/001

Regulatory notes

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

Interactions

657 interactions on record for lactulose.

Graded by severity as the source publishes them — 263 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

Lactulose · interactions on record

657 records

  • 263 moderate
  • 18 minor
  • 376 info

Most severe, free to view

  • CisaprideA03FA02moderate
  • OndansetronA04AA01moderate
  • GranisetronA04AA02moderate
  • DolasetronA04AA04moderate
  • 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

Lactulose in 13 other countries

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

All lactulose products

Authorised across Europe · EMA

The same active substance is authorised in 28 EEA countries. Names it is sold under:

  • Austria · Duphalac Fruit, Lactulose Genericon
  • Belgium · Bifiteral, Duphalac
  • Bulgaria · Дуфалак, Лактулакс
  • Cyprus · Duphalac
  • Czechia · Duphalac, Lactulosa Biomedica
  • Germany · Bifiteral, Bifiteral Mit Pflaumenaroma
  • Denmark · Lactulose Orifarm, Medilax
  • Estonia · Duphalac, Duphalac Fruit
  • Spain · Duphalac, Lactulosa Lainco
  • Finland · Duphalac, Duphalac Fruit
  • France · Duphalac, Lactulose Arrow
  • United Kingdom (Northern Ireland) · Lactolax, Lactulose
  • Greece · Duphafruit, Duphalac
  • Croatia · Portalak, Portalak Efekt
  • Iceland · Medilax
  • Italy · Duphalac, Epalfen Eps
  • Lithuania · Duphalac, Duphalac Fruit
  • Luxembourg · Bifiteral, Duphalac
  • Latvia · Duphalac Fruit, Lactulose Mip
  • Malta · Duphalac, Lactulose
  • Netherlands · Duphalac, Duphalac Fruit
  • Norway · Duphalac, Duphalac Med Fruktsmak
  • Poland · Duphalac, Duphalac Fruit
  • Portugal · Duphalac, Duphalac Ameixa
  • Romania · Duphalac Fruit, Lactecon
  • Sweden · Duphalac, Laktulos Cooper
  • Slovenia · Prorektal
  • Slovakia · Duphalac, Lactecon

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/710a2c36-e1c7-467a-86ba-d6696ddfa122
GET /v1/drugs/710a2c36-e1c7-467a-86ba-d6696ddfa122?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": "Oral solution",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "A06AD",
    "A06AD11"
  ],
  "strength": null,
  "pa_number": "PA0773/004/001",
  "substances": [
    "Lactulose"
  ],
  "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)",
  "market_info": "Not marketed",
  "authorised_at": "03/06/2011",
  "dispensing_status": "Product not subject to medical prescription",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

See everything about lactulose.

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.