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 (Orphacol®) cannot be endorsed for use within NHS Wales for the treatment of inborn errors in primary bile acid synthesis due to 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency in infants, children and adolescents aged one month to 18 years and adults. |
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Medicine details |
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| Medicine name | cholic acid (Orphacol®) | |
| Formulation | 50 mg and 250 mg capsule | |
| Reference number | 929 | |
| Indication | Treatment of inborn errors in primary bile acid synthesis due to 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency in infants, children and adolescents aged one month to 18 years and adults |
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| Company | Laboratoires CTRS | |
| BNF chapter | Nutrition & blood | |
| Submission type | Non-submission | |
| Status | Not endorsed (Statement of Advice) | |
| Date of issue | 26/02/2014 | |