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Gavreto | European Medicines Agency (EMA)

By: forbesmagzine

Date:

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Overview

The marketing authorisation for Gavreto has been withdrawn at the request of the marketing-authorisation holder.

English (EN)
(236 KB – PDF)

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български (BG)
(249.82 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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español (ES)
(193.34 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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čeština (CS)
(231.06 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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dansk (DA)
(186.78 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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Deutsch (DE)
(199 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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eesti keel (ET)
(170.51 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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ελληνικά (EL)
(256.48 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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français (FR)
(197.29 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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hrvatski (HR)
(222.31 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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italiano (IT)
(185.24 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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latviešu valoda (LV)
(234.46 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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lietuvių kalba (LT)
(225.85 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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magyar (HU)
(226.16 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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Malti (MT)
(234.25 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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Nederlands (NL)
(195.16 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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polski (PL)
(229.22 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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português (PT)
(193.14 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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română (RO)
(227.17 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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slovenčina (SK)
(225.98 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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slovenščina (SL)
(218.09 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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Suomi (FI)
(182.23 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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svenska (SV)
(184.88 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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English (EN)
(2.45 MB – PDF)

First published: Last updated:

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Product information

English (EN)
(1.4 MB – PDF)

First published: Last updated:

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български (BG)
(2.1 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

View

español (ES)
(1.53 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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čeština (CS)
(1.72 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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dansk (DA)
(1.48 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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Deutsch (DE)
(1.58 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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eesti keel (ET)
(1.49 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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ελληνικά (EL)
(2.22 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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français (FR)
(1.64 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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hrvatski (HR)
(1.81 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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íslenska (IS)
(1.48 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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italiano (IT)
(1.55 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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latviešu valoda (LV)
(1.91 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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lietuvių kalba (LT)
(1.94 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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magyar (HU)
(1.9 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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Malti (MT)
(1.94 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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Nederlands (NL)
(1.35 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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norsk (NO)
(1.46 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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polski (PL)
(1.86 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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português (PT)
(1.43 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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română (RO)
(1.91 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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slovenčina (SK)
(1.8 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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slovenščina (SL)
(1.73 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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Suomi (FI)
(1.53 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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svenska (SV)
(1.42 MB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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Latest procedure affecting product information:
T/0021

17/07/2024

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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).

English (EN)
(47.08 KB – PDF)

First published: Last updated:

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български (BG)
(76.12 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

View

español (ES)
(54.98 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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čeština (CS)
(67.16 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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dansk (DA)
(55.66 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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Deutsch (DE)
(50.81 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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eesti keel (ET)
(42.8 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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ελληνικά (EL)
(75.33 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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français (FR)
(55.75 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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hrvatski (HR)
(67.35 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

View

íslenska (IS)
(49.46 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

View

italiano (IT)
(60.61 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

View

latviešu valoda (LV)
(68.18 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

View

lietuvių kalba (LT)
(71.81 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

View

magyar (HU)
(67.14 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

View

Malti (MT)
(69.63 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

View

Nederlands (NL)
(49.28 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

View

norsk (NO)
(53.45 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

View

polski (PL)
(77.24 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

View

português (PT)
(52.92 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

View

română (RO)
(72.99 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

View

slovenčina (SK)
(69.71 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

View

slovenščina (SL)
(57.72 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

View

Suomi (FI)
(48.23 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

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svenska (SV)
(42.93 KB – PDF)

First published: 09/12/2021Last updated: 17/01/2025

View

Product details

Name of medicine

Gavreto

Active substance

pralsetinib

International non-proprietary name (INN) or common name

pralsetinib

Therapeutic area (MeSH)

Carcinoma, Non-Small-Cell Lung

Anatomical therapeutic chemical (ATC) code

L01EX23

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.

Direct healthcare professional communications (DHPC)

Further information on Gavreto

English (EN)
(93.49 KB – PDF)

First published:

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forbesmagzine
forbesmagzinehttps://worlddesks.com

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