Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Prac-Tic   
Auth. number : EU/2/06/066
INN : pyriprole
ATC: Anatomical main group: QP - Antiparasitic products, insecticides and repellents
Therapeutic subgroup: QP53 - Ectoparaciticides, insecticides and repellents
Pharmacological subgroup: QP53A - Ectoparasiticides for topical use, incl. insecticides
Chemical subgroup: QP53AX - Other ectoparasiticides for topical use
Chemical substance: QP53AX26 - Pyriprole
(See WHO ATCvet Index)
Indication: Treatment and prevention of flea infestation (Ctenocephalides canis and C. felis) in dogs. Efficacy against new infestations with fleas persists for a minimum of 4 weeks.
Treatment and prevention of tick infestation (Ixodes ricinus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor reticulatus, Dermacentor variabilis, Amblyomma americanum) in dogs. Efficacy against ticks persists for 4 weeks.
Marketing Authorisation Holder: Novartis Sanidad Animal S.L.
Calle de la Marina, 206, E-08013 Barcelona , España

  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
20/12/2006 Centralised - Authorisation EMEA/V/C/103 (2006)7017 of 18/12/2006
06/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/V/C/103/IB/2
27/08/2007 Centralised - Variation EMEA/V/C/103/II/1 (2007)4047 of 23/08/2007
25/02/2008 Centralised - Variation EMEA/V/C/103/IB/3
Updated with Decision(2008)5589 of 26/09/2008
23/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/103/II/4
30/09/2008 Centralised - Variation (2008)5589 of 26/09/2008
26/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/V/C/103/IA/5
12/03/2010 Centralised - Variation EMEA/V/C/103/IB/6/G
Updated with Decision(2010)6907 of 30/09/2010
05/10/2010 Centralised - Variation (2010)6907 of 30/09/2010
10/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/V/C/103/WS/3/G
18/11/2011 Centralised - Renewal EMEA/V/C/103/R/8 (2011)8517 of 16/11/2011
13/12/2012 Centralised - Variation EMEA/V/C/103/II/11
Updated with Decision(2013)9491 of 13/12/2013
17/12/2013 Centralised - Yearly update (2013)9491 of 13/12/2013
06/06/2014 Centralised - Variation EMEA/V/C/103/IB/15