Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Zolvix   
Auth. number : EU/2/09/101
INN : monepantel
ATC: Anatomical main group: QP - Antiparasitic products, insecticides and repellents
Therapeutic subgroup: QP52 - Anthelmintics
Pharmacological subgroup: QP52A - Anthelmintics
Chemical subgroup: QP52AX - Other anthelmintic agents
Chemical substance: QP52AX09 - Monepantel
(See WHO ATCvet Index)
Indication: Treatment and control of gastro-intestinal nematode infections and associated diseases in sheep including lambs, hoggets, breeding rams and ewes.
Marketing Authorisation Holder: Novartis Healthcare A/S
Lyngbyvej 172, DK-2100 København, Danmark

  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 continues to be 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
06/11/2009 Centralised - Authorisation EMEA/V/C/154 (2009)8667 of 04/11/2009
17/11/2010 Centralised - Variation EMEA/V/C/154/IA/2
19/01/2011 Centralised - Variation EMEA/V/C/154/II/1/G (2011)296 of 17/01/2011
23/02/2011 Centralised - Variation EMEA/V/C/154/IB/3/G
16/03/2011 Centralised - Variation EMEA/V/C/154/WS/3/G
23/08/2011 Centralised - Variation EMEA/V/C/154/II/4 (2011)6081 of 19/08/2011
10/07/2013 Centralised - Variation EMEA/V/C/154/IAin/10
07/11/2013 Centralised - Variation EMEA/V/C/154/II/9