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fidaxomicin (Dificlir®)

 

Following non-submission

AWMSG advice

Status: Not endorsed (Statement of Advice)

In the absence of a submission from the holder of the marketing authorisation, fidaxomicin (Dificlir®) cannot be endorsed for use within NHS Wales for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in paediatric patients from birth to < 18 years of age. Consideration should be given to official guidelines on the appropriate use of antibacterial agents. Please refer to the AWMSG position statement on the appraisal of antimicrobial medicines

 Statement of Advice (SOA): fidaxomicin (Dificlir) 2076 (PDF, 86Kb)

Medicine details

Medicine name fidaxomicin (Dificlir®)
Formulation 200 mg film-coated tablet
Reference number 2076
Indication

Treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in paediatric patients from birth to < 18 years of age. Consideration should be given to official guidelines on the appropriate use of antibacterial agents

Company Tillotts Pharma UK Ltd
BNF chapter Infections
Submission type Non-submission
Status Not endorsed (Statement of Advice)
Date of issue 24/06/2021
Further information

AWMSG position statement on the appraisal of antimicrobial medicines

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