Zinplava

Merck Sharp & Dohme B.V.,Waarderweg 39,2031 BN Haarlem,The Netherlands🇪🇺 European Union

EMA Page

Authorised Date: Jan 18, 2017
Approval ID: 793744e10d16d602
Products: 2 listed
Opinion Adopted: N/A

Overview Summary

No summary available.

Therapeutic & Classification

Therapeutic Indication

### Therapeutic indication Zinplava is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI.

Therapeutic Area (MeSH)

Enterocolitis, Pseudomembranous

ATC Code

J06BB21

ATC Item

xj 06 bb 21

Pharmacotherapeutic Group

Immune sera and immunoglobulins

Active Substances

Active Substance (Summary)

Bezlotoxumab

INN / Common Names

bezlotoxumab

Active Substance Details

Substance	CAS	Monograph
Bezlotoxumab	N/A	Bezlotoxumab

Quick Info

Approval ID793744e10d16d602

Product NumberN/A

StatusAuthorised

Authorised DateJan 18, 2017

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Zinplava

Medicine Name

Zinplava

Aliases

N/A

Regulatory Flags

Orphan medicineUnknown

Generic medicineUnknown

BiosimilarUnknown

Conditional approvalUnknown

Exceptional circumstancesUnknown

Accelerated assessmentUnknown

Additional monitoringUnknown

Advanced therapyUnknown

Source Links

EMA Source

No risk management plan link.

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