Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Dexdomitor   
Auth. number : EU/2/02/033
INN : dexmedetomidine hydrochloride
ATC: Anatomical main group: QN - Nervous system
Therapeutic subgroup: QN05 - Psycholeptics
Pharmacological subgroup: QN05C - Hypnotics and sedatives
Chemical subgroup: QN05CM - Other hypnotics and sedatives
Chemical substance: QN05CM18 - Dexmedetomidine
(See WHO ATCvet Index)
Indication: Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats. Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures.Premedication in dogs and cats before induction and maintenance of general anaesthesia.
Marketing Authorisation Holder: Orion Corporation
Orionintie 1, FI-02200 Espoo, Suomi

  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
05/09/2002 Centralised - Authorisation EMEA/V/C/70 (2002)3320 of 30/08/2002
30/06/2003 Centralised - Variation EMEA/V/C/70/II/1 (2003)2118 of 26/06/2003
04/03/2004 Centralised - Variation EMEA/V/C/70/II/2 (2004)720 of 02/03/2004
28/07/2004 Centralised - Variation EMEA/V/C/70/IB/4
Updated with Decision(2005)1927 of 21/06/2005
23/06/2005 Centralised - Variation EMEA/V/C/70/IB/4 (2005)1927 of 21/06/2005
28/06/2005 Centralised - Variation EMEA/V/C/70/II/5 (2005)1974 of 24/06/2005
13/10/2005 Centralised - Notification EMEA/V/C/70/N/6
Updated with Decision(2006)3246 of 11/07/2006
09/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/V/C/70/IA/7
13/07/2006 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/70/T/8 (2006)3246 of 11/07/2006
06/08/2007 Centralised - Renewal EMEA/V/C/70/R/9 (2007)3813 of 02/08/2007
27/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/V/C/70/IB/10
16/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/70/IA/11
16/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/70/IA/12
08/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/70/IB/13
08/02/2008 Centralised - Variation EMEA/V/C/70/IA/15
Updated with Decision(2008)4535 of 13/08/2008
03/03/2008 Centralised - Variation EMEA/V/C/70/IB/14
Updated with Decision(2008)4535 of 13/08/2008
15/08/2008 Centralised - Variation EMEA/V/C/70/II/16, 17 (2008)4535 of 13/08/2008
20/11/2009 Centralised - Variation EMEA/V/C/70/II/18 (2009)9203 of 18/11/2009
14/01/2010 Corrigendum (2010)118 of 12/01/2010
03/09/2012 Centralised - Variation EMEA/V/C/70/X/19 (2012)6135 of 30/08/2012
04/10/2012 Centralised - Variation EMEA/V/C/70/IB/20
Updated with Decision(2012)7768 of 25/10/2012
30/10/2012 Centralised - Variation (2012)7768 of 25/10/2012
14/03/2014 Centralised - Variation EMEA/V/C/70/IA/28
07/11/2014 Centralised - Variation EMEA/V/C/70/IA/30
19/12/2014 Centralised - Variation