Spain· ES:46197
DUPHALAC 667 MG/ML SOLUCION ORAL
A medicinal product containing lactulosa, registered in Spain by Cooper Consumer Health B.V..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- lactulosa
- Manufacturer
- Cooper Consumer Health B.V.
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 2026
Packs & prices · 2
2 priced- cima_codigo748582800EUR 13.25
- cima_codigo748590200EUR 5.45
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Lactulosa in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandDuphalacCooper Consumer Health B.V.
- PolandDuphalacCooper Consumer Health B.V.
- IrelandBrillphalac 3.335 g/5 ml oral solutionBrillpharma (Ireland) Limited
- NorwayDuphalacCooper Consumer Health B.V.
- United StatesConstuloseActavis Pharma, Inc.
- United KingdomBifiteral 10g oral powder sachetsImported (Germany)
- GermanyBifiteralCooper Consumer Health Deutschland Gmbh
- BelgiumBifiteral 66.7 g/100 mlCooper Consumer Health
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
- Finland · Duphalac, Duphalac Fruit
- France · Duphalac, Lactulose Arrow
- United Kingdom (Northern Ireland) · Lactolax, Lactulose
- Greece · Duphafruit, Duphalac
- Croatia · Portalak, Portalak Efekt
- Ireland · Brillphalac, Lactecon
- 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 AEMPS CIMA (Spain). 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/8d4c2712-a1d0-4f3f-af4e-33c0a551c454 GET /v1/drugs/8d4c2712-a1d0-4f3f-af4e-33c0a551c454?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.
{
"cpresc": "Medicamento Sujeto A Prescripción Médica",
"estado": "{\"aut\":-52707600000}",
"nregistro": "46197",
"substance": "lactulosa"
}See everything about lactulosa.
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.