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TENKASI (oritavancin) - Acute bacterial skin.
Reason for request
Summary of opinion
Favourable opinion for reimbursement in the treatment of acute bacterial skin and skin structure infections (ABSSSI), only in adult patients with infections of a certain degree of seriousness, for whom a staphylococcal aetiology is demonstrated or suspected (suppurative infections) and methicillin resistance is demonstrated or strongly suspected.
No clinical added value of the new form with a dose strength of 1,200 mg of oritavancin compared to the form already available with a dose strength of 400 mg of oritavancin.
Clinical Benefit
| Substantial |
The Committee considers that the clinical benefit of TENKASI (oritavancin) 1,200 mg is substantial in the treatment of acute bacterial skin and skin structure infections (ABSSSI), only in adult patients with infections of a certain degree of seriousness, for whom a staphylococcal aetiology is demonstrated or suspected (suppurative infections) and methicillin resistance is demonstrated or strongly suspected. |
Clinical Added Value
| no clinical added value |
This medicinal product is a range supplement that does not provide any clinical added value (CAV V) compared to the form already listed. |
