DUPHALAC

This brand name is authorized in Austria, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Lithuania, Malta, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa

Active ingredients

The drug DUPHALAC contains one active pharmaceutical ingredient (API):

1 Lactulose
UNII 9U7D5QH5AE - LACTULOSE

Lactulose is a synthetic disaccharide which is metabolised by gastro-intestinal bacterial flora to low molecular weight acids (chiefly lactic and acetic acids). There is no endogenous metabolising enzyme in the human gut. Its mode of action in constipation is as an osmotic agent producing soft stools.

Read about Lactulose

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
DUPHALAC Oral solution Health Products Regulatory Authority (IE) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
A06AD11 Lactulose A Alimentary tract and metabolism → A06 Laxatives → A06A Laxatives → A06AD Osmotically acting laxatives
Discover more medicines within A06AD11

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 500214050031818, 500216070034803, 500220040045107
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 361560812
Country: EE Ravimiamet Identifier(s): 1051131, 1063213, 1063224, 1117493, 1354676, 1354755, 1354777, 1354788, 1354799, 1356151
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 46197, 60189
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 082669, 088287, 450346, 450353
Country: FR Base de données publique des médicaments Identifier(s): 60155329, 62729121
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 15029, 15031, 15035
Country: HK Department of Health Drug Office Identifier(s): 32072
Country: IE Health Products Regulatory Authority Identifier(s): 22551, 22594
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1007049, 1007050, 1007051, 1032888, 1033341, 1050949, 1050950, 1050951, 1050952, 1067322, 1070746, 1075415
Country: MT Medicines Authority Identifier(s): MA1507/00501, PI1438/05101A
Country: NG Registered Drug Product Database Identifier(s): 04-1331
Country: NL Z-Index G-Standaard, PRK Identifier(s): 120162, 892
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 793
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100196595, 100220371, 100222766, 100304820, 100414632
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W68670001, W68670002, W68670003, W68670004, W68670005, W68670006
Country: SG Health Sciences Authority Identifier(s): 02818P
Country: TN Direction de la Pharmacie et du Médicament Identifier(s): 9253121, 9253122
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699820570217, 8699820570224
Country: ZA Health Products Regulatory Authority Identifier(s): 28/11.5/0427, K/11.5/180

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