Overview
The marketing authorisation for Lartruvo has been revoked by the European Commission.
Lartruvo : EPAR - Summary for the public
Product information
Lartruvo : EPAR - Product Information
Latest procedure affecting product information: PSUSA/00010541/201704
11/01/2018
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Lartruvo : EPAR - All Authorised presentations
Product details
- Name of medicine
- Lartruvo
- Active substance
- Olaratumab
- International non-proprietary name (INN) or common name
- olaratumab
- Therapeutic area (MeSH)
- Sarcoma
- Anatomical therapeutic chemical (ATC) code
- L01XC27
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic 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 (see section 5.1).
Assessment history
Lartruvo Article 20 referral - CHMP assessment report
Lartruvo : EPAR - Procedural steps taken and scientific information after authorisation
Lartruvo-H-C-PSUSA-10541-201704 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation