Lartruvo
olaratumab
Table of contents
Overview
The marketing authorisation for Lartruvo has been revoked by the European Commission.
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 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 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 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 |
Product information
11/01/2018 Lartruvo - EMEA/H/C/004216 - PSUSA/00010541/201704
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).
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
News
-
26/04/2019
-
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 January 201901/02/2019
-
23/01/2019
-
21/09/2016
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16/09/2016