Raxone

Chiesi Farmaceutici S.p.A,Via Palermo 26/A,43122 Parma,Italy🇪🇺 European Union

EMA Page

Authorised Date: Sep 8, 2015
Approval ID: 94a75b2d0f4bba5c
Products: 8 listed
Opinion Adopted: N/A

Overview Summary

This is a summary of the European public assessment report (EPAR) for Raxone. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Raxone. For practical information about using Raxone, patients should read the package leaflet or contact their doctor or pharmacist.

Therapeutic & Classification

Therapeutic Indication

### Therapeutic indication Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy (LHON).

Therapeutic Area (MeSH)

Optic Atrophy, Hereditary, Leber

ATC Code

N06BX13

ATC Item

idebenone

Pharmacotherapeutic Group

N/A

Active Substances

Active Substance (Summary)

idebenone

INN / Common Names

idebenone

Active Substance Details

Substance	CAS	Monograph
idebenone	N/A	艾地苯醌

Quick Info

Approval ID94a75b2d0f4bba5c

Product NumberN/A

StatusAuthorised

Authorised DateSep 8, 2015

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Raxone

Medicine Name

Raxone

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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