XERAVA Powder for solution for infusion Ref.[51548] Active ingredients: Eravacycline

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: PAION Deutschland GmbH, HeussstraรŸe 25, 52078 Aachen, Germany

Product name and form

Xerava 100 mg powder for concentrate for solution for infusion.

Pharmaceutical Form

Powder for concentrate for solution for infusion (powder for concentrate).

Pale yellow to dark yellow cake.

Qualitative and quantitative composition

Each vial contains 100 mg eravacycline.

After reconstitution, each mL contains 20 mg eravacycline.

After further dilution, 1 mL contains 0.6 mg eravacycline.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Eravacycline

Eravacycline is an antibacterial drug. Its mechanism of action involves the disruption of bacterial protein synthesis by binding to the 30S ribosomal subunit thus preventing the incorporation of amino acid residues into elongating peptide chains.

List of Excipients

Mannitol (E421)
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)

Pack sizes and marketing

10 mL Type I glass vial with butyl rubber stopper and aluminium cap.

Pack sizes: 1 vial, 10 vials and multipacks containing 12 (12 packs of 1) vials.

Not all pack sizes may be marketed.

Marketing authorization holder

PAION Deutschland GmbH, HeussstraรŸe 25, 52078 Aachen, Germany

Marketing authorization dates and numbers

EU/1/18/1312/003
EU/1/18/1312/004
EU/1/18/1312/005

Date of first authorisation: 20 September 2018

Drugs

Drug Countries
XERAVA Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United States

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