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, ciprofloxacin/fluocinolone (Cetraxal Plus®) cannot be endorsed for use within NHS Wales for the treatment in adults and in children aged 6 months and older for the following infections: Acute otitis externa (AOE); Acute otitis media in patients with tympanostomy tubes (AOMT) caused by ciprofloxacin susceptible microorganisms. Please refer to the AWMSG position statement on the appraisal of antimicrobial medicines. |
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Medicine details |
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| Medicine name | ciprofloxacin/fluocinolone (Cetraxal Plus®) | |
| Formulation | 3 mg per ml/0.25 mg per ml ear drops | |
| Reference number | 4063 | |
| Indication | Treatment in adults and in children aged 6 months and older for the following infections: Acute otitis externa (AOE); Acute otitis media in patients with tympanostomy tubes (AOMT) caused by ciprofloxacin susceptible microorganisms. |
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| Company | Aspire Pharma Ltd | |
| BNF chapter | Ear, nose & oropharynx | |
| Submission type | Non-submission | |
| Status | Not endorsed (Statement of Advice) | |
| Date of issue | 28/03/2019 | |
| Further information AWMSG position statement on the appraisal of antimicrobial medicines |
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