Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: THERAVIA, 16 Rue Montrosier, 92200 Neuilly-sur-Seine, France
Orphacol 50 mg hard capsules.
Orphacol 250 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule (capsule). Orphacol 50 mg capsules: Oblong, opaque, blue and white capsule. Orphacol 250 mg capsules: Oblong, opaque, green and white capsule. |
Orphacol 50 mg capsules: Each hard capsule contains 50 mg of cholic acid.
Orphacol 250 mg capsules: Each hard capsule contains 250 mg of cholic acid.
Excipient(s) with known effect: Lactose monohydrate (145.79 mg per capsule of 50 mg and 66.98 mg per capsule of 250 mg).
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
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. |
| List of Excipients |
|---|
|
Capsule content: Lactose monohydrate Capsule shell Orphacol 50 mg capsule: Gelatin (bovine origin) Capsule shell Orphacol 250 mg capsule: Gelatin (bovine origin) |
PVC/PVDC-aluminium blister of 10 capsules.
Pack sizes: 30, 60, 120.
Not all pack sizes may be marketed.
THERAVIA, 16 Rue Montrosier, 92200 Neuilly-sur-Seine, France
Orphacol 50 mg capsule:
EU/1/13/870/001
EU/1/13/870/002
EU/1/13/870/003
Orphacol 250 mg capsule:
EU/1/13/870/004
EU/1/13/870/005
EU/1/13/870/006
Date of first authorisation: 12 September 2013
Date of latest renewal: 24 April 2019
| Drug | Countries | |
|---|---|---|
| ORPHACOL | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom |
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