Source: Health Products Regulatory Authority (IE) Revision Year: 2018 Publisher: Ferrer Internacional, S.A., Gran VĂa Carlos III, 94, 08028, Barcelona, Spain
Dubine 10 mg/g cream.
| Pharmaceutical Form |
|---|
|
Cream. Pale yellow, homogeneous cream. |
Each gram of cream contains 10 mg of ozenoxacin.
Excipient(s) with known effect: Each gram of cream contains 1mg of benzoic acid (E-210), 150 mg of propylene glycol and 40 mg of stearyl alcohol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ozenoxacin |
Ozenoxacin is a non-fluorinated quinolone with a dual inhibitory activity against bacterial DNA replication enzymes, DNA gyrase A and topoisomerase IV. Ozenoxacin is characterized by its potency and bactericidal activity against clinical bacterial isolates involved in skin infections, including S. aureus and S. pyogenes. |
| List of Excipients |
|---|
|
Macrogol stearate |
Aluminium tube with a white screw cap. The tube has an epoxy-phenolic internal lacquer and a sealant lacquer at the tube end.
Dubine is available in tubes containing 10 g of cream.
Ferrer Internacional, S.A., Gran VĂa Carlos III, 94, 08028, Barcelona, Spain
PA1744/003/001
Date of first authorisation: 16th June 2017
| Drug | Countries | |
|---|---|---|
| DUBINE | Poland |
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