Tigecycline Accord (tigecycline)
- Region
- 🇪🇺 EU
- Active substance
- tigecycline
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Soft Tissue Infections; Intraabdominal Infections; Bacterial Infections; Skin Diseases, Infectious
- EU approval
- Fri 17 Apr 2020
- Designations
- Generic
- Application
- EMEA/H/C/005114
- ATC
- J01AA12
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Tygacil Authorised · Pfizer Europe MA EEIG
- 🇪🇺 Tigecycline Accord Application withdrawn · Accord Healthcare Ltd
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.