CHMP recommends approval of extension to marketing terms for Tenkasi in acute bacterial skin and skin structure infections.- Menarini
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Tenkasi (oritavancin) from Menarini International Operations Luxembourg S.A.
The CHMP adopted an extension to the existing indication to include treatment of paediatric patients. For information, the full indication will be as follows: Tenkasi is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients aged 3 months and older. Tenkasi was previously named Orbactiv.
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