Champix

Pfizer Europe MA EEIG,Boulevard de la Plaine 17,1050 Bruxelles,Belgium🇪🇺 European Union

EMA Page

Authorised Date: Sep 25, 2006
Approval ID: 65e79d52f587af65
Products: 2 listed
Opinion Adopted: N/A

Overview Summary

This is a summary of the European public assessment report (EPAR) for Champix. 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 Champix.

Therapeutic & Classification

Therapeutic Indication

### Therapeutic indication Champix is indicated for smoking cessation in adults.

Therapeutic Area (MeSH)

N/A

ATC Code

N07BA03

ATC Item

varenicline

Pharmacotherapeutic Group

Other nervous system drugs

Active Substances

Active Substance (Summary)

varenicline

INN / Common Names

N/A

Active Substance Details

Substance	CAS	Monograph
varenicline	N/A	伐尼克兰

Quick Info

Approval ID65e79d52f587af65

Product NumberN/A

StatusAuthorised

Authorised DateSep 25, 2006

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Champix

Medicine Name

Champix

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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