DUPHALAC

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

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 more about Lactulose

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

ATC Group		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)
BR	Câmara de Regulação do Mercado de Medicamentos	500214050031818, 500216070034803, 500220040045107
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	361560812
EE	Ravimiamet	1051131, 1063213, 1063224, 1117493, 1354676, 1354755, 1354777, 1354788, 1354799, 1356151
ES	Centro de información online de medicamentos de la AEMPS	46197, 60189
FI	Lääkealan turvallisuus- ja kehittämiskeskus	082669, 088287, 450346, 450353
FR	Base de données publique des médicaments	60155329, 62729121
GB	Medicines & Healthcare Products Regulatory Agency	15029, 15031, 15035
HK	Department of Health Drug Office	32072
HR	Agencija za lijekove i medicinske proizvode	HR-H-686529569, HR-H-833932438
IE	Health Products Regulatory Authority	22551, 22594
LT	Valstybinė vaistų kontrolės tarnyba	1007049, 1007050, 1007051, 1032888, 1033341, 1050949, 1050950, 1050951, 1050952, 1067322, 1070746, 1075415
MT	Medicines Authority	MA1507/00501, PI1438/05101A
NG	Registered Drug Product Database	04-1331
NL	Z-Index G-Standaard, PRK	120162, 892
NZ	Medicines and Medical Devices Safety Authority	793
PL	Rejestru Produktów Leczniczych	100196595, 100220371, 100222766, 100304820, 100414632
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W68670001, W68670002, W68670003, W68670004, W68670005, W68670006
SG	Health Sciences Authority	02818P
TN	Direction de la Pharmacie et du Médicament	9253121, 9253122
TR	İlaç ve Tıbbi Cihaz Kurumu	8699820570217, 8699820570224
ZA	Health Products Regulatory Authority	28/11.5/0427, K/11.5/180