Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Scenesse   
Auth. number : EU/1/14/969
Active substance : afamelanotide
Orphan market exclusivity for "Treatment of erythropoietic protoporphyria" (based on designation EU/3/08/541) started on 29/12/2014
   10 years of market exclusivity
   This orphan market exclusivity will expire on 29/12/2024
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
Devonshire House, 60 Goswell Road, London EC1M 7AD, United Kingdom
EPAR and active package presentations

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
29/12/2014 Centralised - Authorisation EMEA/H/C/2548 (2014)10268 of 22/12/2014
27/07/2015 Centralised - Variation EMEA/H/C/2548/IAin/2/G
Updated with Decision(2016)5366 of 12/08/2016
01/12/2015 Centralised - Variation EMEA/H/C/2548/IB/06
Updated with Decision(2016)5366 of 12/08/2016
26/05/2016 Centralised - Annual reassessment EMEA/H/C/2548/S/07
17/08/2016 Centralised - Yearly update (2016)5366 of 12/08/2016