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cholic acid (Cholic Acid FGK®)


Reference No. 1696

Publication date:
14/08/2014


Appraisal information

cholic acid (Cholic Acid FGK®) 50 mg capsule
cholic acid (Cholic Acid FGK®) 250 mg capsule


Company: FGK Representative Service GmbH
BNF category: Gastro-intestinal system
NMG meeting date: Not scheduled
AWMSG meeting date: Not scheduled
   
   
Submission Type: Nonsubmission
Status: Not endorsed
Advice No: Not available
Ratification by Welsh Government: 13/08/2014

Current Progress


Submission
received
NMG
meeting
AWMSG
meeting
Ratification by
Welsh Government

AWMSG 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.
Statement of Advice (SOA)
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