Xerava

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On 26 July 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Xerava, intended for the treatment of complicated intra-abdominal infections in adults. The applicant for this medicinal product is Tetraphase Pharmaceuticals Ireland Limited.

Xerava will be available as a 50-mg powder for concentrate for solution for infusion. The active substance of Xerava is eravacycline, a fluorocycline belonging to the tetracycline group of antibiotics (ATC code: J01AA13). Eravacycline inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, thus preventing the incorporation of amino acid residues into elongating peptide chains.

The benefits with Xerava are its ability to effectively treat complicated intra-abdominal infections. The most common side effects are nausea, vomiting and infusion site phlebitis.

The full indication is:

"Xerava is indicated for the treatment of complicated intra-abdominal infections (cIAI) in adults (see sections 4.4 and 5.1).

Consideration should be given to official guidance on the appropriate use of antibacterial agents."

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Name Language First published Last updated
CHMP summary of positive opinion for Xerava (English only) 2018-07-27  

Key facts

Product details for Xerava
NameXerava
INN or common name

eravacycline

Therapeutic area InfectionBacterial Infections
Active substance

eravacycline

Date opinion adopted26/07/2018
Company name

Tetraphase Pharmaceuticals Ireland Limited

StatusPositive
Application typeInitial authorisation