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
The drug URSOFALK contains one active pharmaceutical ingredient (API):
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1
Ursodeoxycholic acid
UNII 724L30Y2QR - URSODIOL
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The ursodeoxycholic acid converts lithogenic bile in non-lithogenic bile and gradually dissolves the cholesterol gallstones. |
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 |
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 |
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: 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 |
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