Lartruvo
Revoked
This medicine's authorisation has been revoked
olaratumab
MedicineHumanRevoked
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Lartruvo has been revoked by the European Commission.
Lartruvo : EPAR - Summary for the public
English (EN) (528.34 KB - PDF)
First published: Last updated:
български (BG) (597.72 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
español (ES) (527.76 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
čeština (CS) (578.67 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
dansk (DA) (526.59 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
Deutsch (DE) (529.16 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
eesti keel (ET) (525.89 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
ελληνικά (EL) (601.38 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
français (FR) (528.02 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
hrvatski (HR) (537.96 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
italiano (IT) (526.55 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
latviešu valoda (LV) (577.96 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
lietuvių kalba (LT) (541.33 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
magyar (HU) (572.3 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
Malti (MT) (579.62 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
Nederlands (NL) (527.11 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
polski (PL) (579.33 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
português (PT) (525.28 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
română (RO) (539.42 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
slovenščina (SL) (571.31 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
Suomi (FI) (525.26 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
svenska (SV) (523.37 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
Product information
Lartruvo : EPAR - Product Information
English (EN) (901.3 KB - PDF)
First published: Last updated:
български (BG) (1.93 MB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
español (ES) (1010.5 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
čeština (CS) (1.34 MB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
dansk (DA) (947.43 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
Deutsch (DE) (827.56 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
eesti keel (ET) (841.25 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
ελληνικά (EL) (1.76 MB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
français (FR) (990.48 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
hrvatski (HR) (1.01 MB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
íslenska (IS) (1.2 MB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
italiano (IT) (1.03 MB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
latviešu valoda (LV) (1.45 MB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
lietuvių kalba (LT) (1.09 MB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
magyar (HU) (1.45 MB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
Malti (MT) (1.53 MB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
Nederlands (NL) (959.37 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
norsk (NO) (998 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
polski (PL) (1.48 MB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
português (PT) (812.93 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
română (RO) (1.04 MB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
slovenčina (SK) (1.44 MB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
slovenščina (SL) (1.48 MB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
Suomi (FI) (952.72 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
svenska (SV) (889.51 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
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
English (EN) (455.85 KB - PDF)
First published: Last updated:
български (BG) (519.57 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
español (ES) (497.61 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
čeština (CS) (481.69 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
dansk (DA) (460.13 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
Deutsch (DE) (456.41 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
eesti keel (ET) (457.97 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
ελληνικά (EL) (493.93 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
français (FR) (456.7 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
hrvatski (HR) (468.76 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
íslenska (IS) (16.69 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
italiano (IT) (463.86 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
latviešu valoda (LV) (490.44 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
lietuvių kalba (LT) (471.65 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
magyar (HU) (476.63 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
Malti (MT) (484.37 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
Nederlands (NL) (460.37 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
norsk (NO) (460.84 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
polski (PL) (486.05 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
português (PT) (459.3 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
română (RO) (472.1 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
slovenčina (SK) (483.87 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
slovenščina (SL) (506.47 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
Suomi (FI) (493.84 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
svenska (SV) (455.73 KB - PDF)
First published: 23/11/2016Last updated: 02/09/2019
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).
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
- Revocation of marketing authorisation
- 22/07/2019
- Revision
- 3
Assessment history
Lartruvo Article 20 referral - CHMP assessment report
Reference Number: EMA/254126/2019
English (EN) (3.04 MB - PDF)
First published:
Lartruvo : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (511.88 KB - PDF)
First published: Last updated:
Lartruvo-H-C-PSUSA-10541-201704 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
English (EN) (504.3 KB - PDF)
First published: Last updated:
Lartruvo : EPAR - Public assessment report
AdoptedReference Number: EMA/CHMP/742133/2016
English (EN) (5.78 MB - PDF)
First published: Last updated:
CHMP summary of positive opinion for Lartruvo
AdoptedReference Number: EMA/CHMP/589981/2016
English (EN) (536.99 KB - PDF)
First published: Last updated:
News on Lartruvo
Related content
- Clinical data (initial marketing authorisation)
More information on Lartruvo
This product was originally designated an orphan medicine on 12 February 2015. Lartruvo was withdrawn from the Community register of orphan medicinal products by the European Commission in July 2019 at the time of the withdrawal of the marketing authorisation.
More information on Lartruvo
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