Following non-submission
AWMSG advice |
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| Status: Not endorsed (Statement of Advice) | ||
In the absence of a submission from the holder of the marketing authorisation, cholic acid (Cholic Acid FGK®) cannot be endorsed for use within NHS Wales for the treatment of inborn errors in primary bile acid synthesis due to sterol 27-hydroxylase (presenting as cerebrotendinous xanthomatosis, CTX) deficiency, 2- (or α-) methylacyl-CoA racemase (AMACR) deficiency or cholesterol 7α-hydroxylase (CYP7A1) deficiency in infants, children and adolescents aged 1 month to 18 years and adults. |
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Medicine details |
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| Medicine name | cholic acid (Cholic Acid FGK®) | |
| Formulation | 50 mg and 250 mg capsule | |
| Reference number | 1696 | |
| Indication | Treatment of inborn errors in primary bile acid synthesis due to sterol 27-hydroxylase (presenting as cerebrotendinous xanthomatosis, CTX) deficiency, 2- (or α-) methylacyl-CoA racemase (AMACR) deficiency or cholesterol 7α-hydroxylase (CYP7A1) deficiency in infants, children and adolescents aged 1 month to 18 years and adults |
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| Company | FGK Representative Service GmbH | |
| BNF chapter | Gastro-intestinal system | |
| Assessment type | Non-submission | |
| Status | Not endorsed (Statement of Advice) | |
| Date of issue | 13/08/2014 | |