ellaOne

Laboratoire HRA Pharma,200 avenue de Paris,92 320 CHATILLON,France🇪🇺 European Union

EMA Page

Authorised Date: May 15, 2009
Approval ID: 0b3673a2b3e94f89
Products: 2 listed
Opinion Adopted: N/A

Overview Summary

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

Therapeutic & Classification

Therapeutic Indication

### Therapeutic indication Emergency contraception within 120 hours (five days) of unprotected sexual intercourse or contraceptive failure.

Therapeutic Area (MeSH)

Contraception, Postcoital

ATC Code

G03AD02

ATC Item

ulipristal

Pharmacotherapeutic Group

N/A

Active Substances

Active Substance (Summary)

ulipristal

INN / Common Names

ulipristal acetate

Active Substance Details

Substance	CAS	Monograph
ulipristal	N/A	Ulipristal

Quick Info

Approval ID0b3673a2b3e94f89

Product NumberN/A

StatusAuthorised

Authorised DateMay 15, 2009

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

ellaOne

Medicine Name

ellaOne

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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