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Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Duloxetine Boehringer Ingelheim
Auth. number : EU/1/08/471
INN : Duloxetine
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N06 - Psychoanaleptics
Pharmacological subgroup: N06A - Antidepressants
Chemical subgroup: N06AX - Other antidepressants
Chemical substance: N06AX21 - Duloxetine
(See WHO ATC Index)
Indication: Treatment of diabetic peripheral neuropathic pain in adults.
Marketing Authorisation Holder: Boehringer Ingelheim International GmbH
Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
10/10/2008 Centralised - Authorisation EMEA/H/C/1007 (2008)5967 of 08/10/2008
16/01/2009 Centralised - Variation EMEA/H/C/1007/IB/4
16/01/2009 Centralised - Variation EMEA/H/C/1007/IB/3
24/02/2009 Centralised - Variation EMEA/H/C/1007/IA/6
12/03/2009 Centralised - Variation EMEA/H/C/1007/II/1 (2009)1841 of 10/03/2009
02/04/2009 Centralised - Variation EMEA/H/C/1007/IA/10
08/04/2009 Centralised - Variation EMEA/H/C/1007/II/2 (2009)2715 of 03/04/2009
27/04/2009 Centralised - Variation EMEA/H/C/1007/IB/9
28/04/2009 Centralised - Variation EMEA/H/C/1007/II/7
16/07/2009 Centralised - Variation EMEA/H/C/1007/II/8 (2009)5746 of 14/07/2009
21/09/2009 Centralised - Variation EMEA/H/C/1007/II/11 (2009)7145 of 17/09/2009
16/11/2009 Centralised - Variation EMEA/H/C/1007/IB/12
24/11/2009 Centralised - Variation EMEA/H/C/1007/IB/13
24/11/2009 Centralised - Variation EMEA/H/C/1007/IB/13
25/11/2009 Centralised - Variation EMEA/H/C/1007/IA/14
07/12/2009 Centralised - Variation EMEA/H/C/1007/IA/15
Updated with Decision(2010)1826 of 15/03/2010
17/03/2010 Centralised - Variation (2010)1826 of 15/03/2010
28/05/2010 Centralised - Withdrawal (2010)3495 of 26/05/2010