Zinplava (bezlotoxumab)
- Region
- 🇪🇺 EU
- Active substance
- bezlotoxumab
- Company
- Merck Sharp & Dohme B.V.
- Status
- Withdrawn
- Therapeutic area
- Enterocolitis, Pseudomembranous
- CHMP opinion
- Thu 10 Nov 2016
- EU approval
- Wed 18 Jan 2017
- Application
- EMEA/H/C/004136
- ATC
- J06BB21
- Official record
- www.ema.europa.eu
Indication
Zinplava is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI.
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.