🇪🇺 Oral Suspension Tedizolid Phosphate in European Union

EMA authorised Oral Suspension Tedizolid Phosphate on 23 March 2015

Marketing authorisation

EMA — authorised 23 March 2015

  • Application: EMEA/H/C/002846
  • Marketing authorisation holder: Merck Sharp & Dohme B.V.
  • Local brand name: Sivextro
  • Indication: Sivextro tablets are indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults, adolescents and children weighing at least 35 kg.Consideration should be given to official guidance on the appropriate use of antibacterial agents. Sivextro powder for concentrate for solution for infusion is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) from birth. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
  • Status: approved

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Other Infectious Disease approved in European Union

Frequently asked questions

Is Oral Suspension Tedizolid Phosphate approved in European Union?

Yes. EMA authorised it on 23 March 2015.

Who is the marketing authorisation holder for Oral Suspension Tedizolid Phosphate in European Union?

Merck Sharp & Dohme B.V. holds the EU marketing authorisation.