Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031, BN Haarlem, The Netherlands
Sivextro 200 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Oval (13.8 mm long by 7.4 mm wide) yellow film-coated tablet debossed with “TZD” on the obverse side and “200” on the reverse side. |
Each film-coated tablet contains 200 mg tedizolid phosphate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tedizolid |
Tedizolid is an oxazolidinone prodrug. The antibacterial activity of tedizolid is mediated by binding to the 50S subunit of the bacterial ribosome resulting in inhibition of protein synthesis. Tedizolid is primarily active against Gram-positive bacteria. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose Film coat: Polyvinyl alcohol |
6 × 1 tablets in aluminum/Polyethylene Terephthalate (PET)/Paper foil and polyvinyl chloride (PVC)/polyvinylidene chloride (PVdC) clear film perforated child-resistant unit-dose blisters.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031, BN Haarlem, The Netherlands
EU/1/15/991/001
Date of first authorisation: 23 March 2015
Date of latest renewal: 09 January 2020
| Drug | Countries | |
|---|---|---|
| SIVEXTRO | Austria, Brazil, Estonia, Spain, Finland, France, Ireland, Japan, Lithuania, Mexico, Poland, Singapore, United Kingdom, United States |
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