This is a summary of the European public assessment report (EPAR) for Tygacil. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Tygacil.
Tygacil : EPAR - Summary for the public (PDF/81.94 KB)
First published: 04/04/2007
Last updated: 31/07/2015
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Pfizer Europe MA EEIG
|Date of issue of marketing authorisation valid throughout the European Union||
09/04/2019 Tygacil - EMEA/H/C/000644 - N/0108
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Antibacterials for systemic use
Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections:
- Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections
- Complicated intra-abdominal infections (cIAI)
Tygacil should be used only in situations where other alternative antibiotics are not suitable.
Consideration should be given to official guidance on the appropriate use of antibacterial agents. appropriate use of antibacterial agents.