Vaniqa

Almirall, S.A.,Ronda General Mitre, 151,ES-08022 Barcelona,Spain🇪🇺 European Union

EMA Page

Authorised Date: Mar 19, 2001
Approval ID: c5229b2ac87c923f
Products: 1 listed
Opinion Adopted: N/A

Overview Summary

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

Therapeutic & Classification

Therapeutic Indication

### Therapeutic indication Treatment of facial hirsutism in women.

Therapeutic Area (MeSH)

Hirsutism

ATC Code

D11AX

ATC Item

其它皮肤病用药

Pharmacotherapeutic Group

Other dermatological preparations

Active Substances

Active Substance (Summary)

Eflornithine

INN / Common Names

eflornithine

Active Substance Details

Substance	CAS	Monograph
Eflornithine	N/A	Eflornithine

Quick Info

Approval IDc5229b2ac87c923f

Product NumberN/A

StatusAuthorised

Authorised DateMar 19, 2001

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Vaniqa

Medicine Name

Vaniqa

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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