Lartruvo

Withdrawn

This medicine's authorisation has been withdrawn

olaratumab

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The marketing authorisation for Lartruvo has been revoked by the European Commission.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

Authorisation details

• EMA product number:
  EMEA/H/C/004216
• 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.

• 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.

• Marketing authorisation holder:
  Eli Lilly Nederland B.V.

  Papendorpseweg 83; 3528 BJ Utrecht; The Netherlands

• Opinion adopted:
  15/09/2016
• Marketing authorisation issued:
  09/11/2016
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

Lartruvo Article 20 referral - CHMP assessment report

Reference Number: EMA/254126/2019

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

Initial marketing authorisation documents

Lartruvo : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/742133/2016

CHMP summary of positive opinion for Lartruvo

AdoptedReference Number: EMA/CHMP/589981/2016