Duloxetine Boehringer Ingelheim
Withdrawn
This medicine's authorisation has been withdrawn
duloxetine
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
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Public Assessment Report for Duloxetine Boehringer Ingelheim is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
P46/008
07/12/2009
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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).
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
PsychoanalepticsTherapeutic indication
Treatment of diabetic peripheral neuropathic pain in adults.
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