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ursodeoxycholic acid 500mg film-coated tablets (Ursofalk®)

Advice

following an abbreviated submission:

ursodeoxycholic acid 500mg film-coated tablets (Ursofalk®) is accepted for use within NHS Scotland.

Indication under review: for the dissolution of cholesterol gallstones in the gall bladder. The gallstones must not show as shadows on X-ray images and should not exceed 15mm in diameter. The gall bladder must be functioning despite the gallstone(s). For the treatment of primary biliary cirrhosis (PBC), provided there is no decompensated hepatic cirrhosis.

Ursodeoxycholic acid 500mg film-coated tablets have demonstrated bioequivalence to ursodeoxycholic acid capsules at the same dose. Relative costs may vary slightly depending on the pack size used.

Drug Details

Drug Name: ursodeoxycholic acid 500mg film-coated tablets (Ursofalk®)
SMC Drug ID: 889/13
Manufacturer: Dr Falk Pharma UK
Indication: For the dissolution of cholesterol gallstones in the gall bladder. The gallstones must not show as shadows on X-ray images and should not exceed 15mm in diameter. The gall bladder must be functioning despite the gallstone(s).
BNF Category:
Sub Category: 1.9 Drugs affecting intestinal secretions
Submission Type: Abbreviated Submission
Status: Accepted
Date Advice Published: 12 August 2013

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