Overview
The marketing authorisation for Nodetrip has been withdrawn at the request of the marketing-authorisation holder.
Nodetrip (previously Xeristar) : Medicine overview
Xeristar - EPAR - Risk-management-plan summary
Product information
Nodetrip (previously Xeristar) : EPAR - Product Information
Latest procedure affecting product information: WITHDRAWAL
12/05/2021
This medicine’s product information is available in all official EU languages.
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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
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
PsychoanalepticsTherapeutic indication
- Treatment of major depressive disorder;
- Treatment of diabetic peripheral neuropathic pain;
- Treatment of generalised anxiety disorder;
- Xeristar is indicated in adults.
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
Questions and answers on the refusal of a change to the marketing authorisation for Ariclaim, Cymbalta and Xeristar
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Cymbalta / Xeristar
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