Clopidogrel Krka d.d. (previously Zopya)

Norpharm Regulatory Services Ltd🇪🇺 European Union

EMA Page

Authorised Date: Sep 20, 2009
Approval ID: 46ddd1cbf137e719
Products: 1 listed
Opinion Adopted: N/A

Overview Summary

This is a summary of the European public assessment report (EPAR) for Clopidogrel Krka d.d. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel Krka d.d.

Therapeutic & Classification

Therapeutic Indication

N/A

Therapeutic Area (MeSH)

N/A

ATC Code

B01AC03

ATC Item

picotamide

Pharmacotherapeutic Group

N/A

Active Substances

Active Substance (Summary)

clopidogrel (as hydrochloride)

INN / Common Names

N/A

Active Substance Details

Substance	CAS	Monograph
clopidogrel (as hydrochloride)	N/A	clopidogrel (as hydrochloride)

Quick Info

Approval ID46ddd1cbf137e719

Product NumberN/A

StatusAuthorised

Authorised DateSep 20, 2009

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Clopidogrel Krka d.d. (previously Zopya)

Medicine Name

Clopidogrel Krka d.d. (previously Zopya)

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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