Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ledaga   
Auth. number : EU/1/16/1171
Active substance : chlormethine
Orphan market exclusivity for "Treatment of cutaneous T-cell lymphoma" (based on designation EU/3/12/963) started on 07/03/2017
   10 years of market exclusivity
   This orphan market exclusivity will expire on 07/03/2027
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01A - Alkylating agents
Chemical subgroup: L01AA - Nitrogen mustard analogues
Chemical substance: L01AA05 - Chlormethine
(See WHO ATC Index)
Indication: Ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF type CTCL) in adult patients
Marketing Authorisation Holder: Actelion Registration Ltd
Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, 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
07/03/2017 Centralised - Authorisation EMEA/H/C/2826 (2017)1603 of 03/03/2017
28/06/2017 Centralised - Variation EMEA/H/C/2826/IA/1
20/11/2017 Centralised - Variation EMEA/H/C/2826/IG/839