This brand name is authorized in Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom
The drug ORPHACOL contains one active pharmaceutical ingredient (API):
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1
Cholic acid
UNII G1JO7801AE - CHOLIC ACID
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Cholic acid is the predominant primary bile acid in man. In patients with inborn deficiency of 3β-Hydroxy-Δ5−C27-steroid oxidoreductase and Δ4-3-Oxosteroid-5β-reductase, the biosynthesis of primary bile acids is reduced or absent. The rational basis for treatment consists of restoration of the bile aciddependent component of bile flow enabling restoration of biliary secretion and biliary elimination of toxic metabolites; inhibition of the production of the toxic bile acid metabolites by negative feedback on cholesterol 7α-hydroxylase, which is the rate-limiting enzyme in bile acid synthesis; and improvement of the patient’s nutritional status by correcting intestinal malabsorption of fats and fat-soluble vitamins. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| ORPHACOL Hard capsule | European Medicines Agency (EU) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| A05AA03 | 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: EE | Ravimiamet | Identifier(s): 1624935, 1624946, 1624957, 1624968, 1624979, 1624980 |
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 113870001, 113870004 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 62882708, 63316225 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 290082, 290086 |
| Country: IT | Agenzia del Farmaco | Identifier(s): 043028012, 043028024, 043028036, 043028048, 043028051, 043028063 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1071217, 1071218, 1071219, 1071220, 1071221, 1071222 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100312860, 100312877 |
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