Nodetrip (previously Xeristar)

duloxetine

Overview
Authorisation details
Product information
Assessment history

Withdrawn

This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Nodetrip has been withdrawn at the request of the marketing-authorisation holder.

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Nodetrip (previously Xeristar) : Medicine overview (PDF/682.05 KB)

First published: 20/11/2009
Last updated: 22/06/2021
EMA/559525/2020
- Bulgarian
  (PDF/749.16 KB)
- Croatian
  (PDF/705.14 KB)
- Czech
  (PDF/722.78 KB)
- Danish
  (PDF/680.94 KB)
- Dutch
  (PDF/681.77 KB)
- Estonian
  (PDF/670.78 KB)
- Finnish
  (PDF/680.34 KB)
- French
  (PDF/684.74 KB)
- German
  (PDF/685.84 KB)
- Greek
  (PDF/729.55 KB)
- Hungarian
  (PDF/722.57 KB)
- Italian
  (PDF/681.27 KB)
- Latvian
  (PDF/741.61 KB)
- Lithuanian
  (PDF/706.01 KB)
- Maltese
  (PDF/725.29 KB)
- Polish
  (PDF/724.84 KB)
- Portuguese
  (PDF/693.56 KB)
- Romanian
  (PDF/702.41 KB)
- Slovak
  (PDF/723.55 KB)
- Slovenian
  (PDF/721 KB)
- Spanish
  (PDF/682.3 KB)
- Swedish
  (PDF/681.49 KB)
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Xeristar - EPAR - Risk-management-plan summary (PDF/817.27 KB)

First published: 08/10/2019
Last updated: 22/06/2021

This EPAR was last updated on 22/06/2021

Authorisation details

Product details
Name	Nodetrip (previously Xeristar)
Agency product number	EMEA/H/C/000573
Active substance	duloxetine
International non-proprietary name (INN) or common name	duloxetine
Therapeutic area (MeSH)	Anxiety Disorders Depressive Disorder, Major Diabetic Neuropathies
Anatomical therapeutic chemical (ATC) code	N06AX21

Publication details
Marketing-authorisation holder	Esteve Pharmaceuticals, S.A.
Revision	32
Date of issue of marketing authorisation valid throughout the European Union	17/12/2004
Contact address	Passeig de la Zona Franca, 109 08038 Barcelona Spain

Product information

12/05/2021 Nodetrip (previously Xeristar) - EMEA/H/C/000573 - WITHDRAWAL

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Nodetrip (previously Xeristar) : EPAR - Product Information (PDF/793.23 KB)

First published: 17/08/2009
Last updated: 22/06/2021
- Bulgarian
  (PDF/1.14 MB)
- Croatian
  (PDF/971.91 KB)
- Czech
  (PDF/1.07 MB)
- Danish
  (PDF/803.66 KB)
- Dutch
  (PDF/819.45 KB)
- Estonian
  (PDF/847.23 KB)
- Finnish
  (PDF/819.54 KB)
- French
  (PDF/924.45 KB)
- German
  (PDF/802.9 KB)
- Greek
  (PDF/1.12 MB)
- Hungarian
  (PDF/1.02 MB)
- Icelandic
  (PDF/826.56 KB)
- Italian
  (PDF/862.17 KB)
- Latvian
  (PDF/1.04 MB)
- Lithuanian
  (PDF/987.92 KB)
- Maltese
  (PDF/1.06 MB)
- Norwegian
  (PDF/823.65 KB)
- Polish
  (PDF/1.04 MB)
- Portuguese
  (PDF/892.28 KB)
- Romanian
  (PDF/1016.84 KB)
- Slovak
  (PDF/1.02 MB)
- Slovenian
  (PDF/1016.38 KB)
- Spanish
  (PDF/845.16 KB)
- Swedish
  (PDF/803.62 KB)

Other EU languages available icon 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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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Nodetrip (previously Xeristar) : EPAR - All Authorised presentations (PDF/579.72 KB)

First published: 13/03/2019
Last updated: 22/06/2021
- Bulgarian
  (PDF/651.64 KB)
- Croatian
  (PDF/599.41 KB)
- Czech
  (PDF/603.98 KB)
- Danish
  (PDF/578.85 KB)
- Dutch
  (PDF/581.01 KB)
- Estonian
  (PDF/581.03 KB)
- Finnish
  (PDF/581.54 KB)
- French
  (PDF/579.35 KB)
- German
  (PDF/579.59 KB)
- Greek
  (PDF/625.04 KB)
- Hungarian
  (PDF/614.29 KB)
- Icelandic
  (PDF/582.84 KB)
- Italian
  (PDF/579.38 KB)
- Latvian
  (PDF/616.63 KB)
- Lithuanian
  (PDF/602.72 KB)
- Maltese
  (PDF/612.43 KB)
- Norwegian
  (PDF/579.04 KB)
- Polish
  (PDF/615.42 KB)
- Portuguese
  (PDF/579.12 KB)
- Romanian
  (PDF/594.98 KB)
- Slovak
  (PDF/603.19 KB)
- Slovenian
  (PDF/611.31 KB)
- Spanish
  (PDF/579.12 KB)
- Swedish
  (PDF/579.6 KB)

Pharmacotherapeutic group

Psychoanaleptics

Therapeutic indication

Treatment of major depressive disorder;
Treatment of diabetic peripheral neuropathic pain;
Treatment of generalised anxiety disorder;
Xeristar is indicated in adults.

Assessment history

Changes since initial authorisation of medicine

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Nodetrip (previously Xeristar) : EPAR - Procedural steps taken and scientific information after authorisation (PDF/832.28 KB)

First published: 17/08/2009
Last updated: 22/06/2021
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Xeristar-H-C-PSUSA-00001187-201408 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/622.5 KB)

First published: 26/10/2015
Last updated: 22/06/2021
EMA/PRAC/154100/2015
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Xeristar-H-C-573-P46-P45-045.1 : EPAR - Assessment Report (PDF/2.66 MB)

Adopted

First published: 08/03/2013
Last updated: 22/06/2021
EMA/121591/2013
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Xeristar-H-C-573-P46-0040 : EPAR - Assessment Report (PDF/1 MB)

Adopted

First published: 17/01/2013
Last updated: 22/06/2021
EMA/18171/2013
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Xeristar-H-C-573-WS-0076 : EPAR - Assessment Report - Variation (PDF/1.54 MB)

Adopted

First published: 13/06/2012
Last updated: 22/06/2021
EMA/285264/2012
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Questions and answers on the refusal of a change to the marketing authorisations for Ariclaim, Cymbalta and Xeristar (duloxetine) - Outcome of re-examination (PDF/513 KB)

Adopted

First published: 18/11/2011
Last updated: 22/06/2021
EMA/901723/2011
- Bulgarian
  (PDF/613.62 KB)
- Czech
  (PDF/582.79 KB)
- Danish
  (PDF/514.25 KB)
- Dutch
  (PDF/513.34 KB)
- Estonian
  (PDF/513.23 KB)
- Finnish
  (PDF/514.1 KB)
- French
  (PDF/514.54 KB)
- German
  (PDF/517.01 KB)
- Greek
  (PDF/623.44 KB)
- Hungarian
  (PDF/574.38 KB)
- Italian
  (PDF/577.69 KB)
- Latvian
  (PDF/587.08 KB)
- Lithuanian
  (PDF/544.26 KB)
- Maltese
  (PDF/581.85 KB)
- Polish
  (PDF/580.11 KB)
- Portuguese
  (PDF/512.74 KB)
- Romanian
  (PDF/537.43 KB)
- Slovak
  (PDF/655.65 KB)
- Slovenian
  (PDF/652.72 KB)
- Spanish
  (PDF/514.39 KB)
- Swedish
  (PDF/612.7 KB)
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Questions and answers on the refusal of a change to the marketing authorisation for Ariclaim, Cymbalta and Xeristar (PDF/496.52 KB)

Adopted

First published: 22/07/2011
Last updated: 07/08/2018
EMA/CHMP/580268/2011
- Bulgarian
  (PDF/613.55 KB)
- Czech
  (PDF/582.79 KB)
- Danish
  (PDF/514.25 KB)
- Dutch
  (PDF/513.33 KB)
- Estonian
  (PDF/513.25 KB)
- Finnish
  (PDF/514.1 KB)
- French
  (PDF/514.55 KB)
- German
  (PDF/517.02 KB)
- Greek
  (PDF/623.45 KB)
- Hungarian
  (PDF/574.42 KB)
- Italian
  (PDF/577.7 KB)
- Latvian
  (PDF/587.07 KB)
- Lithuanian
  (PDF/544.27 KB)
- Maltese
  (PDF/581.86 KB)
- Polish
  (PDF/580.11 KB)
- Portuguese
  (PDF/512.74 KB)
- Romanian
  (PDF/537.44 KB)
- Slovak
  (PDF/577.52 KB)
- Slovenian
  (PDF/574.43 KB)
- Spanish
  (PDF/514.39 KB)
- Swedish
  (PDF/513.11 KB)
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Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Cymbalta / Xeristar (PDF/593.45 KB)

Adopted

First published: 23/10/2008
Last updated: 22/06/2021
EMEA/551181/2008
- Bulgarian
  (PDF/748.33 KB)
- Czech
  (PDF/692.79 KB)
- Danish
  (PDF/594.19 KB)
- Dutch
  (PDF/594.53 KB)
- Estonian
  (PDF/593.94 KB)
- Finnish
  (PDF/594.31 KB)
- French
  (PDF/594.41 KB)
- German
  (PDF/593.79 KB)
- Greek
  (PDF/745.74 KB)
- Hungarian
  (PDF/683.94 KB)
- Italian
  (PDF/594.41 KB)
- Latvian
  (PDF/712.89 KB)
- Lithuanian
  (PDF/672.48 KB)
- Maltese
  (PDF/722.16 KB)
- Polish
  (PDF/694.47 KB)
- Portuguese
  (PDF/594.79 KB)
- Romanian
  (PDF/672.41 KB)
- Slovak
  (PDF/690.35 KB)
- Slovenian
  (PDF/683.86 KB)
- Spanish
  (PDF/594.71 KB)
- Swedish
  (PDF/594.1 KB)
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Xeristar-H-C-573-II-0026 : EPAR - Refusal assessment report - Variation (PDF/2.77 MB)

First published: 23/10/2008
Last updated: 22/06/2021
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Xeristar-H-C-573-II-0027 : EPAR - Assessment Report - Variation (PDF/905.79 KB)

First published: 18/09/2008
Last updated: 22/06/2021
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CHMP post authorisation summary of positive opinion for Xeristar on 26 June 2008 (PDF/586.77 KB)

Adopted

First published: 26/06/2008
Last updated: 22/06/2021
EMEA/CHMP/335994/2008
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Xeristar-H-C-573-II-0004 : EPAR - Scientific Discussion - Variation (PDF/791.96 KB)

Adopted

First published: 07/02/2006
Last updated: 22/06/2021
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Xeristar-573-H-C-A18-652 : EPAR - Scientific Conclusion (PDF/681.31 KB)

Adopted

First published: 07/02/2006
Last updated: 22/06/2021

Initial marketing-authorisation documents

News

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 November 2011

18/11/2011

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Nodetrip (previously Xeristar)

Table of contents

Overview