Pharmaceuticals - Community Register


Community register of veterinary medicinal products


Product information

Invented name: Zolvix   
Auth. number : EU/2/09/101
Active substance : 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 - bovine rhinotracheitis virus (ibr)
(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: Elanco Europe Ltd
Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom
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
6/11/2009 Centralised - Authorisation EMEA/V/C/154 (2009)8667 of 4/11/2009
17/11/2010 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/V/C/154/IB/3/G
16/03/2011 Centralised - Variation (no change in Commission Decision) 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
Updated with Decision(2014)6041 of 19/08/2014
7/11/2013 Centralised - Variation EMEA/V/C/154/II/9
Updated with Decision(2014)6041 of 19/08/2014
21/08/2014 Centralised - Yearly update (2014)6041 of 19/08/2014
11/11/2014 Centralised - Renewal EMEA/V/C/154/R/13 (2014)8411 of 7/11/2014
5/12/2014 Centralised - Variation EMEA/V/C/154/IB/15
Updated with Decision(2015)8265 of 19/11/2015
23/11/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/154/T/18 (2015)8265 of 19/11/2015
15/07/2016 Centralised - Variation EMEA/V/C/154/IB/19/G
Updated with Decision(2017)5113 of 14/07/2017
3/07/2017 Centralised - Variation EMEA/V/C/154/IG/794/22
18/07/2017 Centralised - Yearly update (2017)5113 of 14/07/2017