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Reason for request
-
Clinical Benefit
| Substantial |
The actual benefit of CILOXAN 3 mg/ml, ear drops solution is substantial in the Marketing Authorisation indications. |
Clinical Added Value
| minor |
In the indication "acute otitis externa" Given, - the demonstrated clinical efficacy of ciprofloxacin (CILOXAN) in acute otitis externa without tympanic perforation, compared with an ear drops solution containing a set combination oftwo antibiotics (aminoglycoside/polypeptide) and a corticosteroid, - the possible use in cases of a perforated eardrum (although the ototoxicity risk contraindicates the intra-auricular use of aminoglycosides), - the microbiological activity towards the main pathogens encountered in this disease (particularly Pseudomonas aeruginosa and Staphylococcus aureus), - the good tolerance profile - the absence of a therapeutic alternative with a Marketing Authorisation in this indication in cases of tympanic perforation, |
| no clinical added value |
In the indication "purulent otorrhea of the mastoid cavity and chronic suppurative otitis media with tympanic perforation" The Committee considers that CILOXAN does not provide an improvement in actual benefit (IAB V) compared with OFLOCET, ear drops solution, which has a Marketing Authorisation (MA of 21/11/1995) in this indication. The Committee recognises that CILOXAN represents a beneficial therapeutic alternative given its good efficacy and tolerance profile and its in vitro microbiological activity towards the main pathogens encountered in this disease (in particular Pseudomonas aeruginosa and Staphylococcus aureus). |
