URSOFALK

This brand name is authorized in Australia, Austria, Croatia, Cyprus, Ecuador, Estonia, Germany, Hong Kong SAR China, Ireland, Israel, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Turkey, UK.

Active ingredients

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

1	Ursodeoxycholic acid UNII 724L30Y2QR - URSODIOL
	The ursodeoxycholic acid converts lithogenic bile in non-lithogenic bile and gradually dissolves the cholesterol gallstones.
	Read more about Ursodeoxycholic acid

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
URSOFALK Capsule, hard	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

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

ATC Group		Classification
A05AA02	Ursodeoxycholic acid	A Alimentary tract and metabolism → A05 Bile and liver therapy → A05A Bile therapy → A05AA Bile acid preparations
Discover more medicines within A05AA02

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
AU	Pharmaceutical Benefits Scheme	11180K, 8448P
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	02144453, 02144536, 02244781, 02244798, 05969102, 05985265, 06972218, 06972224, 10972974, 10972980, 16166961, 16166978
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	22.754-1-07-06
EE	Ravimiamet	1044818, 1063101
GB	Medicines & Healthcare Products Regulatory Agency	139646, 175982, 196215, 200298, 200299, 217141, 28592, 28710, 373938, 377079, 381723, 56519
HK	Department of Health Drug Office	57786, 65379
HR	Agencija za lijekove i medicinske proizvode	HR-H-837713755
IE	Health Products Regulatory Authority	32975, 48530, 48531, 48545, 48569, 68561, 68953
IL	מִשְׂרַד הַבְּרִיאוּת	4884, 7766
LT	Valstybinė vaistų kontrolės tarnyba	1002229, 1005473, 1036970, 1055167
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	222M89
NL	Z-Index G-Standaard, PRK	105759, 106054, 15830
NZ	Medicines and Medical Devices Safety Authority	11194
PL	Rejestru Produktów Leczniczych	100069566, 100250366, 100250768
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W00187001, W00187002, W58363001, W58363002, W58710001, W58710002
SG	Health Sciences Authority	05742P, 14545P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699543150031, 8699543700052
ZA	Health Products Regulatory Authority	43/11.10/0442