awmsg logo



fidaxomicin (Dificlir®)


Reference No. 847

Publication date:
13/12/2012


Appraisal information

fidaxomicin (Dificlir®) 200 mg film-coated tablet


Company: Astellas Pharma Ltd
BNF category: Infections
NMG meeting date: 09/10/2012
AWMSG meeting date: 14/11/2012
   
   
Submission Type: Full Submission
Status: Recommended with restrictions
Advice No: 3712
Ministerial ratification: 11/12/2012

Current Progress


Submission
received
NMG
meeting
AWMSG
meeting
Ministerial
Ratification

AWMSG advice

Fidaxomicin (Dificlir®) is recommended as an option for restricted use within NHS Wales. Fidaxomicin (Dificlir®) should be restricted for use in the following subpopulations within its licensed indication for the treatment of adults with Clostridium difficile infections (CDI), also known as C. difficile-associated diarrhoea (CDAD): - Patients with severe CDI; - Patients with recurrence of CDI. Fidaxomicin (Dificlir®) should be prescribed on the advice of a consultant microbiologist, consistent with Health Protection Agency guidance. Fidaxomicin (Dificlir®) is not recommended for use within NHS Wales outside the specified subpopulations.
Final Appraisal Recommendation (FAR)
Download
AWMSG Secretariat Appraisal Report (ASAR)
Download
Clinical Expert (CE) Summary
Download