Tigecycline Accord is a medicine used to treat adults and children older than eight years with complicated infections of the skin and soft tissue (the tissue below the skin), but not foot infections in people with diabetes. It is also used to treat complicated infections in the abdomen. ‘Complicated’ means that the infection is difficult to treat because it has spread, or the patient has other conditions that makes treatment difficult. Tigecycline Accord should be used only when other antibiotics are not suitable. Before using Tigecycline Accord, doctors should consider official guidance on the appropriate use of antibiotics.
Tigecycline Accord is a ‘generic medicine’. This means that Tigecycline Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Tygacil. For more information on generic medicines, see the question-and-answer document here.
Tigecycline Accord contains the active substance tigecycline.
Tigecycline Accord : EPAR - Medicine overview (PDF/145.5 KB)
First published: 24/04/2020
Tigecycline Accord : EPAR - Risk-management-plan summary (PDF/80.03 KB)
First published: 24/04/2020
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This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
Accord Healthcare S.L.U.
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Tigecycline Accord - EMEA/H/C/005114 -
- 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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Antibacterials for systemic use
Tygecycline Accord is indicated in adults and in children from the age of eight years for the treatment of the following infections (see sections 4.4 and 5.1):
- Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections (see section 4.4)
- Complicated intra-abdominal infections (cIAI)
Tygecycline Accord should be used only in situations where other alternative antibiotics are not suitable (see sections 4.4, 4.8 and 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.