Reason for request

Extension of Inclusion

No clinical benefit demonstrated in the management of complicated intra-abdominal, skin and soft tissue infections in children

  • TYGACIL now has Marketing Authorisation in children aged 8 years and older for the treatment of complicated intra-abdominal infections and complicated skin and soft tissue infections (cSSTIs), except for diabetic foot infections.
  • Its potential benefit is based on its broad spectrum of activity, including Gram (+) and Gram (-) bacteria that are resistant to several antibiotics.
  • The Marketing Authorisation is restricted to clinical situations where no suitable antibiotic is available.
  • Given the characteristics of the product and current uncertainties about its clinical efficacy and safety in severe infections and/or infections caused by multidrug-resistant bacteria, the therapeutic decision must be made in consultation with an antibiotics handling expert.

Clinical Benefit



Clinical Added Value

no clinical added value


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