URSOFALK

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

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 about Ursodeoxycholic acid

Medication package inserts

Below package inserts are available for further reading:

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