Lartruvo

RSS

olaratumab

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Lartruvo has been revoked by the European Commission.

This EPAR was last updated on 02/09/2019

Authorisation details

Product details
Name
Lartruvo
Agency product number
EMEA/H/C/004216
Active substance
Olaratumab
International non-proprietary name (INN) or common name
olaratumab
Therapeutic area (MeSH)
Sarcoma
Anatomical therapeutic chemical (ATC) code
L01XC27
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Publication details
Marketing-authorisation holder
Eli Lilly Nederland B.V.
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
09/11/2016
Contact address

Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Product information

11/01/2018 Lartruvo - EMEA/H/C/004216 - PSUSA/00010541/201704

Other EU languages available icon 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:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic 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

Related content

How useful was this page?

Add your rating
Average
2 ratings