WC500185968

Background
Tigecycline is a glycylcycline antibiotic indicated in adults for the treatment of complicated skin and
soft tissue infections, excluding diabetic foot infections and for complicated intra-abdominal infections.
The CHMP is evaluating an extension of the therapeutic indication for Tygacil, a centrally authorised
product containing tigecycline, to include the treatment of complicated skin and soft tissue infections,
excluding diabetic foot infections and complicated intra-abdominal infections in children of eight yearsand
older.
The PRAC is responsible for providing advice to the CHMP on the necessary updates to the RMP to
support this extension of indication.
Summary of advice
The RMP version 12 for Tygacil (tigecycline) submitted in the context of the extension of
indication variation under evaluation by the CHMP was considered acceptable, provided an
updated RMP and satisfactory responses to the PRAC list of questions are submitted.
The PRAC considered that the safety concerns identified by the MAH are appropriate
(hepatotoxicity grouped, missing information in paediatrics moved to