Tigecycline Accord
tigecycline
Table of contents
Overview
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.
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Tigecycline Accord : EPAR - Medicine overview (PDF/145.5 KB)
First published: 24/04/2020
EMA/134692/2020 -
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Tigecycline Accord : EPAR - Risk-management-plan summary (PDF/80.03 KB)
First published: 24/04/2020
Authorisation details
Product details | |
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Name |
Tigecycline Accord
|
Agency product number |
EMEA/H/C/005114
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Active substance |
Tigecycline
|
International non-proprietary name (INN) or common name |
tigecycline
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
J01AA12
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Generic |
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. |
Publication details | |
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Marketing-authorisation holder |
Accord Healthcare S.L.U.
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Revision |
5
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Date of issue of marketing authorisation valid throughout the European Union |
17/04/2020
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Contact address |
Accord Healthcare S.L.U. |
Product information
06/07/2023 Tigecycline Accord - EMEA/H/C/005114 - IB/0005
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antibacterials for systemic use
Therapeutic indication
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.