Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Profender   
Auth. number : EU/2/05/054
Active substance : Emodepside / Praziquantel
ATC: Anatomical main group: QP - Antiparasitic products, insecticides and repellents
Therapeutic subgroup: QP52 - Anthelmintics
Pharmacological subgroup: QP52A - Anthelmintics
Chemical subgroup: QP52AA - Quinoline derivatives and related substances
Chemical substance: QP52AA51 - Praziquantel, combinations
(See WHO ATCvet Index)
Indication: For cats suffering from, or at risk from, mixed parasitic infections caused by roundworms, tapeworms and lungworms of the following species:

Roundworms (Nematodes)
Toxocara cati (mature adult, immature adult, L4 and L3)
Toxocara cati (L3 larvae) – treatment of queens during late pregnancy to prevent lactogenic transmission to the offspring
Toxascaris leonina (mature adult, immature adult and L4)
Ancylostoma tubaeforme (mature adult, immature adult and L4)

Tapeworms (Cestodes)
Dipylidium caninum (mature adult and immature adult)
Taenia taeniaeformis (adult)
Echinococcus multilocularis (adult)

Lungworms
Aelurostrongylus abstrusus (adult)

For dogs suffering from, or at risk from, mixed parasitic infections caused by roundworms and
tapeworms of the following species:
Roundworms (Nematodes): Toxocara canis (mature adult, immature adult, L4 and L3) Toxascaris leonina (mature adult, immature adult and L4) Ancylostoma caninum (mature adult and immature adult) Uncinaria stenocephala (mature adult and immature adult) Trichuris vulpis (mature adult, immature adult and L4)
Tapeworms (Cestodes):
Dipylidium caninum Taenia spp.
Echinococcus multilocularis (mature adult and immature) Echinococcus granulosus (mature adult and immature)
Marketing Authorisation Holder: Bayer Animal Health GmbH
D-51368 Leverkusen, 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
29/07/2005 Centralised - Authorisation EMEA/V/C/97 (2005)2949 of 27/07/2005
22/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/V/C/97/IA/1
02/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/V/C/97/IA/2
18/01/2007 Centralised - Variation EMEA/V/C/97/II/3 (2007)173 of 16/01/2007
12/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/V/C/97/IA/6
16/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/V/C/97/IB/5
20/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/V/C/97/IA/7
07/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/97/IB/8
27/08/2008 Centralised - Variation EMEA/V/C/97/X/4 (2008)4681 of 25/08/2008
09/09/2008 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/97/T/9 (2008)5019 of 05/09/2008
10/10/2008 Corrigendum (2008)5019 cor of 08/10/2008
16/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/V/C/97/IA/10
11/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/V/C/97/II/11
07/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/97/IB/12
15/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/97/IB/13
07/04/2010 Centralised - Variation EMEA/V/C/97/IB/15
Updated with Decision(2010)4679 of 01/07/2010
06/07/2010 Centralised - Renewal EMEA/V/C/97/R/14 (2010)4679 of 01/07/2010
26/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/97/IAin/16
10/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/V/C/97/IB/7
12/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/V/C/97/IA/18/G
13/12/2012 Centralised - Variation EMEA/V/C/97/II/23
Updated with Decision(2013)644 of 01/02/2013
05/02/2013 Centralised - 2-Monthly update EMEA/V/C/97/II/22, 23 (2013)644 of 01/02/2013
27/06/2014 Centralised - Variation EMEA/V/C/97/IB/26/G
Updated with Decision(2015)4297 of 19/06/2015
11/03/2015 Centralised - Variation EMEA/V/C/97/IAin/30
Updated with Decision(2015)4297 of 19/06/2015
23/06/2015 Centralised - Yearly update (2015)4297 of 19/06/2015
04/03/2016 Centralised - Variation EMEA/V/C/97/IB/35
Updated with Decision(2016)2425 of 18/04/2016
20/04/2016 Centralised - 2-Monthly update EMEA/V/C/97/II/32 (2016)2425 of 18/04/2016