Overview

The marketing authorisation for Lartruvo has been revoked by the European Commission.

Lartruvo : EPAR - Summary for the public

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Product information

Lartruvo : EPAR - Product Information

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Latest procedure affecting product information: PSUSA/00010541/201704

11/01/2018

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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

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español (ES) (497.61 KB - PDF)
čeština (CS) (481.69 KB - PDF)
dansk (DA) (460.13 KB - PDF)
Deutsch (DE) (456.41 KB - PDF)
eesti keel (ET) (457.97 KB - PDF)
ελληνικά (EL) (493.93 KB - PDF)
français (FR) (456.7 KB - PDF)
hrvatski (HR) (468.76 KB - PDF)
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italiano (IT) (463.86 KB - PDF)
latviešu valoda (LV) (490.44 KB - PDF)
lietuvių kalba (LT) (471.65 KB - PDF)
magyar (HU) (476.63 KB - PDF)
Malti (MT) (484.37 KB - PDF)
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português (PT) (459.3 KB - PDF)
română (RO) (472.1 KB - PDF)
slovenčina (SK) (483.87 KB - PDF)
slovenščina (SL) (506.47 KB - PDF)
Suomi (FI) (493.84 KB - PDF)
svenska (SV) (455.73 KB - PDF)

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

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

Lartruvo : EPAR - Public assessment report

CHMP summary of positive opinion for Lartruvo

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