Sivextro (tedizolid phosphate)
- Region
- 🇪🇺 EU
- Active substance
- tedizolid phosphate
- Company
- Merck Sharp & Dohme B.V.
- Status
- Authorised
- Therapeutic area
- Soft Tissue Infections; Skin Diseases, Bacterial
- CHMP opinion
- Thu 22 Jan 2015
- EU approval
- Mon 23 Mar 2015
- Application
- EMEA/H/C/002846
- ATC
- J01XX11
- Official record
- www.ema.europa.eu
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. Sivextro powder for concentrate for solution for infusion is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) from birth. Sivextro powder for oral suspension is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in patients from birth. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Regulatory milestones
No milestones recorded in the last year.
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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.