TYGACIL

Opinions on drugs - Posted on Nov 30 2011 - Updated on Dec 20 2011

Reason for request

Re-assessment of the actual benefit in accordance with article R.163-21 of the Social Security Code. This re-assessment follows a pharmacovigilance alert relating to an increased mortality observed in the course of clinical studies carried out both in indications validated and not validated by the Marketing Authorisation (MA).

Clinical Benefit

Substantial

The actual benefit of the propriety medicinal product remains substantial only in restricted clinical situations, complicated clinical forms of skin and soft tissue infections and intra-abdominal infections involving bacteria sensitive to tigecycline and when alternative treatments are considered inappropriate.