Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Lartruvo   
Auth. number : EU/1/16/1143
Active substance : olaratumab
Orphan market exclusivity for "Treatment of soft tissue sarcoma" (based on designation EU/3/15/1447) started on 11/11/2016
   10 years of market exclusivity
   This orphan market exclusivity will expire on 11/11/2026
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XC - Monoclonal antibodies
Chemical substance: L01XC27 - Antineoplastic agents, monoclonal antibodies
(See WHO ATC Index)
Indication: Lartruvo is indicated in combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin
Marketing Authorisation Holder: Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht, Nederland
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
11/11/2016 Centralised - Authorisation EMEA/H/C/4216/00 (2016)7285 of 09/11/2016
07/04/2017 Centralised - Variation EMEA/H/C/4216/IB/03/G