Source: European Medicines Agency (EU) Revision Year: 2017 Publisher: Leadiant GmbH, Liebherrstr. 22, 80538 Munich, Germany, Telephone: +49 (0)89 5506675 – 0, Fax: +49 (0) 89 55 066 75 25, e-mail: info@leadiantbiosciences.com
Chenodeoxycholic acid Leadiant 250 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Size 0 capsule, 21.7 mm in length with a yellow body and orange cap, containing a white, compressed powder. |
Each hard capsule contains 250 mg of chenodeoxycholic acid.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Chenodeoxycholic acid |
Exogenous chenodeoxycholic acid is used as replacement therapy to restore the feedback inhibition lost due to the deficiency/absence of endogenous chenodeoxycholic acid. In CTX, deficiency of chenodeoxycholic acid causes a lack of feedback of cholesterol 7 alpha hydroxylase (CYP7A1) and HMG CoA reductase, causing increased production of atypical bile acids, bile alcohols and cholestanol that lead to the pathological consequences of the condition. |
| List of Excipients |
|---|
|
Capsule content: Maize starch Capsule shell: Gelatine |
Capsules are packed in polyvinyl chloride (PVC) blisters sealed with aluminium foil and packed in cardboard boxes.
Packs size: 100 capsules.
Leadiant GmbH, Liebherrstr. 22, 80538 Munich, Germany, Telephone: +49 (0)89 5506675 – 0, Fax: +49 (0) 89 55 066 75 25, e-mail: info@leadiantbiosciences.com
EU/1/16/1110/001
Date of first authorisation: 10/04/2017
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