Duloxetine Boehringer Ingelheim

Withdrawn

This medicine's authorisation has been withdrawn

duloxetine

Overview

On the 8th October 2008 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Duloxetine Boehringer Ingelheim, duloxetine, which had been approved for the treatment of diabetic peripheral neuropathic pain in adults. The marketing authorisation holder (MAH) responsible for Duloxetine Boehringer Ingelheim was Boehringer Ingelheim International GmbH. 

The European Commission was notified by a letter dated 12 April 2010 of the MAH’s decision to voluntarily withdraw the marketing authorisation as of the Commission Decision date for Duloxetine Boehringer Ingelheim for commercial reasons. 

Duloxetine Boehringer Ingelheim was not marketed in any European country. On 26th May 2010 the European Commission issued a decision to withdraw the marketing authorisation for Duloxetine Boehringer Ingelheim. 

Pursuant to this decision the European Public Assessment Report for Duloxetine Boehringer Ingelheim is updated to reflect that the marketing authorisation is no longer valid.

Duloxetine Boehringer Ingelheim : EPAR - Summary for the public

Product information

Duloxetine Boehringer Ingelheim : EPAR - Product Information

Duloxetine Boehringer Ingelheim : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Duloxetine Boehringer Ingelheim
• 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 in adults.

Authorisation details

• EMA product number:
  EMEA/H/C/001007
• Marketing authorisation holder:
  Boehringer Ingelheim International GmbH

  Binger Str 173; D-55216 Ingelheim am Rhein; Germany

• Marketing authorisation issued:
  08/10/2008
• Withdrawal of marketing authorisation:
  26/05/2010
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Duloxetine Boehringer Ingelheim : EPAR - Procedural steps taken and scientific information after authorisation

Duloxetine Boehringer Ingelheim-H-C-1007-A46-08 : EPAR - Assessment Report

Reference Number: EMA/18262/2013

Initial marketing authorisation documents

Duloxetine Boehringer Ingelheim : EPAR - Public assessment report

Committee for medicinal products for human use summary of positive opinion for Duloxetine Boehringer Ingelheim

Reference Number: EMEA/CHMP/333730/2008