Portrazza

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Withdrawn

This medicine's authorisation has been withdrawn

necitumumab
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Medicine has been withdrawn at the request of the marketing-authorisation holder.

Portrazza : EPAR - Summary for the public

Reference Number: EMA/14106/2016

English (EN) (661.27 KB - PDF)

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български (BG) (746.85 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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español (ES) (659.55 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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čeština (CS) (736.21 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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dansk (DA) (658.42 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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Deutsch (DE) (662.7 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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eesti keel (ET) (657.54 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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ελληνικά (EL) (758.18 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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français (FR) (661.31 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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hrvatski (HR) (682.1 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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italiano (IT) (658.5 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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latviešu valoda (LV) (734.27 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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lietuvių kalba (LT) (686.09 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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magyar (HU) (729.2 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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Malti (MT) (738.4 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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Nederlands (NL) (659.47 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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polski (PL) (734.44 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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português (PT) (660.7 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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română (RO) (685.29 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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slovenčina (SK) (735.06 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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slovenščina (SL) (726.15 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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Suomi (FI) (659.1 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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svenska (SV) (659.1 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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Portrazza : EPAR - Risk-management-plan summary

English (EN) (755.01 KB - PDF)

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Product information

Portrazza : EPAR - Product Information

English (EN) (1.09 MB - PDF)

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български (BG) (2.33 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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español (ES) (1.21 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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čeština (CS) (1.83 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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dansk (DA) (1.22 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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Deutsch (DE) (1.19 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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eesti keel (ET) (1.27 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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ελληνικά (EL) (2.15 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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français (FR) (1.25 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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hrvatski (HR) (1.32 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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íslenska (IS) (1.29 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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italiano (IT) (1.94 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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latviešu valoda (LV) (2.56 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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lietuvių kalba (LT) (2.12 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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magyar (HU) (1.81 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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Malti (MT) (1.86 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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Nederlands (NL) (1.17 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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norsk (NO) (1.23 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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polski (PL) (1.87 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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português (PT) (1.18 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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română (RO) (1.31 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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slovenčina (SK) (1.71 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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slovenščina (SL) (1.7 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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Suomi (FI) (1.48 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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svenska (SV) (1.14 MB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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Latest procedure affecting product information: WITHDRAWAL
18/02/2021
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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).

Portrazza : EPAR - All Authorised presentations

English (EN) (589.57 KB - PDF)

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български (BG) (632.95 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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español (ES) (590.22 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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čeština (CS) (613.19 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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dansk (DA) (583.9 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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Deutsch (DE) (587.1 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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eesti keel (ET) (589.13 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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ελληνικά (EL) (625.04 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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français (FR) (586.92 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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hrvatski (HR) (599.14 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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íslenska (IS) (582.38 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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italiano (IT) (584.43 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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latviešu valoda (LV) (618.76 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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lietuvių kalba (LT) (602.19 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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magyar (HU) (609.34 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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Malti (MT) (613.8 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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Nederlands (NL) (590.28 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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norsk (NO) (590.13 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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polski (PL) (622.18 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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português (PT) (588.96 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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română (RO) (605.29 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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slovenčina (SK) (616.42 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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slovenščina (SL) (606.7 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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Suomi (FI) (584.67 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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svenska (SV) (583.91 KB - PDF)

First published: 04/03/2016Last updated: 27/07/2021
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Product details

Name of medicine
Portrazza
Active substance
necitumumab
International non-proprietary name (INN) or common name
necitumumab
Therapeutic area (MeSH)
Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
L01

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Portrazza in combination with gemcitabine and cisplatin chemotherapy is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition.

Authorisation details

EMA product number
EMEA/H/C/003886
Marketing authorisation holder
Eli Lilly Nederland B.V.

Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Marketing authorisation issued
15/02/2016
Revision
3

Assessment history

Portrazza : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (722.39 KB - PDF)

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Portrazza : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/15391/2016

English (EN) (5.39 MB - PDF)

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Summary of opinion for Portrazza

AdoptedReference Number: EMA/CHMP/756429/2015

English (EN) (695.54 KB - PDF)

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More information on Portrazza

Public statement on Portrazza : Expiry of the marketing authorisation in the European Union

AdoptedReference Number: EMA/CHMP/390656/2021

English (EN) (115 KB - PDF)

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