Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Scenesse   
Auth. number : EU/1/14/969
INN : afamelanotide
Orphan status based on designation EU/3/08/541 added on 24/12/2014
ATC: Anatomical main group: D - Dermatologicals
Therapeutic subgroup: D02 - Emollients and protectives
Pharmacological subgroup: D02B - Protectives against UV-radiation
Chemical subgroup: D02BB - Protectives against uv-radiation for systemic use
Chemical substance: D02BB02 - Afamelanotide
(See WHO ATC Index)
Indication: Scenesse is indicated for prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
Marketing Authorisation Holder: Clinuvel UK Limited
c/o - Reed Smith, Broadgate Tower, Third Floor, 20 Primrose Street, London, EC2A 2RS, United Kingdom

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
24/12/2014 Centralised - Authorisation EMEA/H/C/2548 (2014)10268 of 22/12/2014