Nodetrip (previously Xeristar)

Withdrawn

This medicine's authorisation has been withdrawn

duloxetine

Overview

On 12 May 2021, the European Commission withdrew the marketing authorisation for Nodetrip (duloxetine) in the EU. The withdrawal was at the request of the marketing authorisation holder, Esteve Pharmaceuticals S.A., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Nodetrip was granted marketing authorisation in the EU on 17 December 2004 for the treatment of major depressive disorder, diabetic peripheral neuropathic pain and generalised anxiety disorder. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2009. 

The European Public Assessment Report (EPAR) for Nodetrip is updated to indicate that the marketing authorisation is no longer valid.

Nodetrip (previously Xeristar) : Medicine overview

Reference Number: EMA/559525/2020

Xeristar - EPAR - Risk-management-plan summary

Product information

Nodetrip : EPAR - Product Information

Nodetrip (previously Xeristar) : EPAR - All Authorised presentations

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
• Withdrawal of marketing authorisation:
  12/05/2021
• Revision:
  32

Assessment history

Changes since initial authorisation of medicine

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

Reference Number: EMA/PRAC/154100/2015

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

AdoptedReference Number: EMA/121591/2013

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

AdoptedReference Number: EMA/18171/2013

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

AdoptedReference Number: EMA/285264/2012

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

AdoptedReference Number: EMA/901723/2011

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

AdoptedReference Number: EMA/CHMP/580268/2011

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

AdoptedReference Number: EMEA/551181/2008

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

AdoptedReference Number: EMEA/CHMP/335994/2008

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

Adopted

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

Adopted

Initial marketing authorisation documents

Xeristar : EPAR - Procedural steps taken before authorisation

Xeristar : EPAR - Scientific Discussion