Tygacil
tigecycline
Table of contents
Overview
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.
Authorisation details
Product details | |
---|---|
Name |
Tygacil
|
Agency product number |
EMEA/H/C/000644
|
Active substance |
Tigecycline
|
International non-proprietary name (INN) or common name |
tigecycline
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
J01AA12
|
Publication details | |
---|---|
Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
29
|
Date of issue of marketing authorisation valid throughout the European Union |
24/04/2006
|
Contact address |
Product information
09/04/2019 Tygacil - EMEA/H/C/000644 - N/0108
Contents
- 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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Pharmacotherapeutic group
Antibacterials for systemic use
Therapeutic indication
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.