Overview

The marketing authorisation for Nodetrip has been withdrawn at the request of the marketing-authorisation holder.

Nodetrip (previously Xeristar) : Medicine overview

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Xeristar - EPAR - Risk-management-plan summary

Product information

Nodetrip (previously Xeristar) : EPAR - Product Information

български (BG) (1.14 MB - PDF)
español (ES) (845.16 KB - PDF)
čeština (CS) (1.07 MB - PDF)
dansk (DA) (803.66 KB - PDF)
Deutsch (DE) (802.9 KB - PDF)
eesti keel (ET) (847.23 KB - PDF)
ελληνικά (EL) (1.12 MB - PDF)
français (FR) (924.45 KB - PDF)
hrvatski (HR) (971.91 KB - PDF)
íslenska (IS) (826.56 KB - PDF)
italiano (IT) (862.17 KB - PDF)
latviešu valoda (LV) (1.04 MB - PDF)
lietuvių kalba (LT) (987.92 KB - PDF)
magyar (HU) (1.02 MB - PDF)
Malti (MT) (1.06 MB - PDF)
Nederlands (NL) (819.45 KB - PDF)
norsk (NO) (823.65 KB - PDF)
polski (PL) (1.04 MB - PDF)
português (PT) (892.28 KB - PDF)
română (RO) (1016.84 KB - PDF)
slovenčina (SK) (1.02 MB - PDF)
slovenščina (SL) (1016.38 KB - PDF)
Suomi (FI) (819.54 KB - PDF)
svenska (SV) (803.62 KB - PDF)

Latest procedure affecting product information: WITHDRAWAL

12/05/2021

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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).

Nodetrip (previously Xeristar) : EPAR - All Authorised presentations

български (BG) (651.64 KB - PDF)
español (ES) (579.12 KB - PDF)
čeština (CS) (603.98 KB - PDF)
dansk (DA) (578.85 KB - PDF)
Deutsch (DE) (579.59 KB - PDF)
eesti keel (ET) (581.03 KB - PDF)
ελληνικά (EL) (625.04 KB - PDF)
français (FR) (579.35 KB - PDF)
hrvatski (HR) (599.41 KB - PDF)
íslenska (IS) (582.84 KB - PDF)
italiano (IT) (579.38 KB - PDF)
latviešu valoda (LV) (616.63 KB - PDF)
lietuvių kalba (LT) (602.72 KB - PDF)
magyar (HU) (614.29 KB - PDF)
Malti (MT) (612.43 KB - PDF)
Nederlands (NL) (581.01 KB - PDF)
norsk (NO) (579.04 KB - PDF)
polski (PL) (615.42 KB - PDF)
português (PT) (579.12 KB - PDF)
română (RO) (594.98 KB - PDF)
slovenčina (SK) (603.19 KB - PDF)
slovenščina (SL) (611.31 KB - PDF)
Suomi (FI) (581.54 KB - PDF)
svenska (SV) (579.6 KB - PDF)

Product details

Name of medicine
Nodetrip (previously Xeristar)
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

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.

Authorisation details

EMA product number
EMEA/H/C/000573
Marketing authorisation holder
Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109
08038 Barcelona
Spain

Opinion adopted
16/09/2004
Marketing authorisation issued
17/12/2004
Revision
32

Assessment history

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

Xeristar-H-C-PSUSA-00001187-201408 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Xeristar-H-C-573-P46-P45-045.1 : EPAR - Assessment Report

Xeristar-H-C-573-P46-0040 : EPAR - Assessment Report

Xeristar-H-C-573-WS-0076 : EPAR - Assessment Report - Variation

Questions and answers on the refusal of a change to the marketing authorisations for Ariclaim, Cymbalta and Xeristar (duloxetine) - Outcome of re-examination

български (BG) (613.62 KB - PDF)
español (ES) (514.39 KB - PDF)
čeština (CS) (582.79 KB - PDF)
dansk (DA) (514.25 KB - PDF)
Deutsch (DE) (517.01 KB - PDF)
eesti keel (ET) (513.23 KB - PDF)
ελληνικά (EL) (623.44 KB - PDF)
français (FR) (514.54 KB - PDF)
italiano (IT) (577.69 KB - PDF)
latviešu valoda (LV) (587.08 KB - PDF)
lietuvių kalba (LT) (544.26 KB - PDF)
magyar (HU) (574.38 KB - PDF)
Malti (MT) (581.85 KB - PDF)
Nederlands (NL) (513.34 KB - PDF)
polski (PL) (580.11 KB - PDF)
português (PT) (512.74 KB - PDF)
română (RO) (537.43 KB - PDF)
slovenčina (SK) (655.65 KB - PDF)
slovenščina (SL) (652.72 KB - PDF)
Suomi (FI) (514.1 KB - PDF)
svenska (SV) (612.7 KB - PDF)

Questions and answers on the refusal of a change to the marketing authorisation for Ariclaim, Cymbalta and Xeristar

български (BG) (613.55 KB - PDF)
español (ES) (514.39 KB - PDF)
čeština (CS) (582.79 KB - PDF)
dansk (DA) (514.25 KB - PDF)
Deutsch (DE) (517.02 KB - PDF)
eesti keel (ET) (513.25 KB - PDF)
ελληνικά (EL) (623.45 KB - PDF)
français (FR) (514.55 KB - PDF)
italiano (IT) (577.7 KB - PDF)
latviešu valoda (LV) (587.07 KB - PDF)
lietuvių kalba (LT) (544.27 KB - PDF)
magyar (HU) (574.42 KB - PDF)
Malti (MT) (581.86 KB - PDF)
Nederlands (NL) (513.33 KB - PDF)
polski (PL) (580.11 KB - PDF)
português (PT) (512.74 KB - PDF)
română (RO) (537.44 KB - PDF)
slovenčina (SK) (577.52 KB - PDF)
slovenščina (SL) (574.43 KB - PDF)
Suomi (FI) (514.1 KB - PDF)
svenska (SV) (513.11 KB - PDF)

Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Cymbalta / Xeristar

български (BG) (748.33 KB - PDF)
español (ES) (594.71 KB - PDF)
čeština (CS) (692.79 KB - PDF)
dansk (DA) (594.19 KB - PDF)
Deutsch (DE) (593.79 KB - PDF)
eesti keel (ET) (593.94 KB - PDF)
ελληνικά (EL) (745.74 KB - PDF)
français (FR) (594.41 KB - PDF)
italiano (IT) (594.41 KB - PDF)
latviešu valoda (LV) (712.89 KB - PDF)
lietuvių kalba (LT) (672.48 KB - PDF)
magyar (HU) (683.94 KB - PDF)
Malti (MT) (722.16 KB - PDF)
Nederlands (NL) (594.53 KB - PDF)
polski (PL) (694.47 KB - PDF)
português (PT) (594.79 KB - PDF)
română (RO) (672.41 KB - PDF)
slovenčina (SK) (690.35 KB - PDF)
slovenščina (SL) (683.86 KB - PDF)
Suomi (FI) (594.31 KB - PDF)
svenska (SV) (594.1 KB - PDF)

Xeristar-H-C-573-II-0026 : EPAR - Refusal assessment report - Variation

Xeristar-H-C-573-II-0027 : EPAR - Assessment Report - Variation

CHMP post authorisation summary of positive opinion for Xeristar on 26 June 2008

Xeristar-H-C-573-II-0004 : EPAR - Scientific Discussion - Variation

Xeristar-573-H-C-A18-652 : EPAR - Scientific Conclusion

Xeristar : EPAR - Procedural steps taken before authorisation

Xeristar : EPAR - Scientific Discussion

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