Zinplava

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

EMA Page

Authorised Date: Jan 18, 2017
Approval ID: 0408bef59b21d970
Products: 1 listed
Opinion Adopted: N/A

Overview Summary

No summary available.

Therapeutic & Classification

Therapeutic Indication

<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>Zinplava is indicated for the prevention of recurrence of <em>Clostridium difficile</em> infection (CDI) in adults at high risk for recurrence of CDI.</p></div>

Therapeutic Area (MeSH)

Enterocolitis, Pseudomembranous

ATC Code

J06BB21

ATC Item

N/A

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 ID0408bef59b21d970

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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