Scenesse

Clinuvel Europe Limited,10 Earlsfort Terrace,Dublin 2 D04 T380,Ireland🇪🇺 European Union

EMA Page

Authorised Date: Dec 22, 2014
Approval ID: a822995ea3a3fa39
Products: 3 listed
Opinion Adopted: N/A

Overview Summary

This is a summary of the European public assessment report (EPAR) for Scenesse. 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 Scenesse. For practical information about using Scenesse, patients should read the package leaflet or contact their doctor or pharmacist.

Therapeutic & Classification

Therapeutic Indication

### Therapeutic indication Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).

Therapeutic Area (MeSH)

N/A

ATC Code

D02BB02

ATC Item

afamelanotide

Pharmacotherapeutic Group

Emollients and protectives

Active Substances

Active Substance (Summary)

afamelanotide

INN / Common Names

N/A

Active Substance Details

Substance	CAS	Monograph
afamelanotide	N/A	Afamelanotide

Quick Info

Approval IDa822995ea3a3fa39

Product NumberN/A

StatusAuthorised

Authorised DateDec 22, 2014

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Scenesse

Medicine Name

Scenesse

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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