Ariclaim

Withdrawn

This medicine's authorisation has been withdrawn

duloxetine

Overview

On 9 July 2018, the European Commission withdrew the marketing authorisation for Ariclaim (duloxetine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Eli Lilly Nederland B.V., which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Ariclaim was originally granted marketing authorisation in the EU on 11 August 2004 for treatment of stress urinary incontinence (SUI) and diabetic peripheral neuropathic pain. The marketing authorisation was initially valid for a 5-year period. It was renewed with unlimited validity in 2009 for the treatment of diabetic peripheral neuropathic pain but Ariclaim is no longer marketed in any EU country. 

Ariclaim is identical to Cymbalta, Duloxetine Lilly and Xeristar, which are also authorised in the EU to treat diabetic peripheral neuropathic pain. The marketing authorisation holder will maintain the marketing authorisation for Cymbalta, Duloxetine Lilly and Xeristar. 

The European Public Assessment Report (EPAR) for Ariclaim is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Ariclaim : EPAR - Summary for the public

Product information

Ariclaim : EPAR - Product Information

Ariclaim : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Ariclaim
• Active substance:
  duloxetine
• International non-proprietary name (INN) or common name:
  duloxetine
• Therapeutic area (MeSH):
  Diabetic Neuropathies
• Anatomical therapeutic chemical (ATC) code:
  N06AX21

Pharmacotherapeutic group

Psychoanaleptics

Therapeutic indication

Treatment of diabetic peripheral neuropathic pain.

Ariclaim is indicated in adults.

Authorisation details

• EMA product number:
  EMEA/H/C/000552
• Marketing authorisation holder:
  Eli Lilly Nederland B.V.

  Papendorpseweg 83; 3528 BJ Utrecht; Netherlands

• Marketing authorisation issued:
  11/08/2004
• Withdrawal of marketing authorisation:
  09/07/2018
• Revision:
  26

Assessment history

Changes since initial authorisation of medicine

Ariclaim : EPAR - Procedural steps taken and scientific information after authorisation

Ariclaim-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

Ariclaim-H-C-552-P46-0039 : EPAR - Assessment Report

AdoptedReference Number: EMA/121591/2013

Ariclaim-H-C-552-P46-0034: EPAR - Assessment Report

Reference Number: EMA/18171/2013

Ariclaim-H-C-552-WS-0076 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/285264/2012

Ariclaim-H-C-552-II-0024 : EPAR - Scientific Discussion - Variation

Adopted

Ariclaim-H-552-A18-652 : EPAR - Scientific Conclusion

Adopted

Initial marketing authorisation documents

Ariclaim : EPAR - Scientific Discussion

Ariclaim : EPAR - Procedural steps taken before authorisation