Tigecycline Accord

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tigecycline

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 24/04/2020

Authorisation details

Product details
Name
Tigecycline Accord
Agency product number
EMEA/H/C/005114
Active substance
Tigecycline
International non-proprietary name (INN) or common name
tigecycline
Therapeutic area (MeSH)
  • Soft Tissue Infections
  • Intraabdominal Infections
  • Bacterial Infections
  • Skin Diseases, Infectious
Anatomical therapeutic chemical (ATC) code
J01AA12
GenericGeneric

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
Marketing-authorisation holder
Accord Healthcare S.L.U.
Date of issue of marketing authorisation valid throughout the European Union
17/04/2020
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

Tigecycline Accord - EMEA/H/C/005114 -

Contents

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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.

Assessment history

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