Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Clomicalm   
Auth. number : EU/2/98/007
Active substance : Clomipramine hydrochloride
ATC: Anatomical main group: QN - Nervous system
Therapeutic subgroup: QN06 - Psychoanaleptics
Pharmacological subgroup: QN06A - Antidepressants
Chemical subgroup: QN06AA - Non-selective monoamine reuptake inhibitors
Chemical substance: QN06AA04 - Clomipramine
(See WHO ATCvet Index)
Indication: As an aid in the treatment of separation-related disorders manifested by destruction and inappropriate elimination (defaecation and urination) and only in combination with behavioural modification techniques
Marketing Authorisation Holder: Novartis Tiergesundheit GmbH
Zielstattstrasse 40, D-81379 München, 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
02/04/1998 Centralised - Authorisation EMEA/V/C/39 (1998)806 of 01/04/1998
09/02/2000 Centralised - Notification EMEA/V/C/39/N/4 (2000)170 of 04/02/2000
23/02/2000 Centralised - Variation EMEA/V/C/39/I/1, 2, 3 (2000)421 of 21/02/2000
27/03/2000 Centralised - Variation (no change in Commission Decision) EMEA/V/C/39/I/5, 6
11/12/2000 Centralised - Variation EMEA/V/C/39/I/7 (2000)3500 of 08/12/2000
09/01/2002 Centralised - Variation (no change in Commission Decision) EMEA/V/C/39/II/9
17/07/2002 Centralised - Variation EMEA/V/C/39/I/10 (2002)2788 of 15/07/2002
27/02/2003 Centralised - Variation (no change in Commission Decision) EMEA/V/C/39/II/11
26/05/2003 Centralised - Renewal EMEA/V/C/39/R/12 (2003)1721 of 19/05/2003
19/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/V/C/39/II/13
29/09/2005 Centralised - Variation EMEA/V/C/39/IA/15
Updated with Decision(2006)225 of 25/01/2006
27/01/2006 Centralised - Variation EMEA/V/C/39/II/14 (2006)225 of 25/01/2006
14/04/2008 Centralised - Renewal EMEA/V/C/39/R/17 (2008)1451 of 10/04/2008