Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Improvac   
Auth. number : EU/2/09/095
INN : Not available
ATC: Anatomical main group: QG - Genito-urinary system and sex hormones
Therapeutic subgroup: QG03 - Sex hormones and modulators of the genital system
Pharmacological subgroup: QG03X - Other sex hormones and modulators of the genital system
Chemical subgroup: QG03XA - Antigonadotropins and similar agents
Chemical substance: QG03XA - Antigonadotropins and similar agents
(See WHO ATCvet Index)
Indication: Induction of antibodies against GnRF to produce a temporary immunological suppression of testicular function. For use as an alternative to physical castration for the reduction of boar taint caused by the key boar taint compound androstenone, in entire male pigs following the onset of puberty.
Another key contributor to boar taint, skatole, may also be reduced as an indirect effect. Aggressive and sexual (mounting) behaviours are also reduced. The onset of immunity (induction of anti-GnRF antibodies) can be expected within 1 week post second vaccination. Reduction of androstenone and skatole levels has been demonstrated from 4 to 6 weeks post second vaccination. This reflects the time needed for clearance of boar taint compounds already present at the time of vaccination as well as the variability of response between individual animals. Reduction of aggressive and sexual (mounting) behaviours can expected from 1 to 2 weeks post second vaccination.
Marketing Authorisation Holder: Zoetis Belgium S.A.
Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

  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
13/05/2009 Centralised - Authorisation EMEA/V/C/136 (2009)3903 of 11/05/2009
23/11/2009 Centralised - Variation EMEA/V/C/136/II/1 (2009)9248 of 19/11/2009
21/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/136/II/2
25/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/136/II/4
25/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/136/II/3
15/04/2010 Centralised - Variation EMEA/V/C/136/IB/5
Updated with Decision(2010)7212 of 14/10/2010
14/07/2010 Centralised - Variation EMEA/V/C/136/IA/6/G
Updated with Decision(2010)7212 of 14/10/2010
18/10/2010 Centralised - Variation (2010)7212 of 14/10/2010
05/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/136/II/8
23/12/2010 Centralised - Variation EMEA/V/C/136/II/7/G (2010)9621 of 20/12/2010
07/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/V/C/136/IB/10
16/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/V/C/136/II/11
07/09/2011 Centralised - Variation EMEA/V/C/136/II/9 (2011)6380 of 05/09/2011
24/05/2012 Centralised - Variation EMEA/V/C/136/IB/15
Updated with Decision(2012)7915 of 29/10/2012
06/09/2012 Centralised - Variation EMEA/V/C/136/IA/17
Updated with Decision(2012)7915 of 29/10/2012
01/11/2012 Centralised - Variation (2012)7915 of 29/10/2012
25/05/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/136/T/20 (2013)3113 of 22/05/2013
05/09/2013 Centralised - Variation EMEA/V/C/136/IAin/21/G
Updated with Decision(2014)2587 of 10/04/2014
12/09/2013 Centralised - Variation EMEA/V/C/136/II/19
Updated with Decision(2014)2587 of 10/04/2014
12/09/2013 Centralised - Variation EMEA/V/C/136/II/18
Updated with Decision(2014)2587 of 10/04/2014
14/04/2014 Centralised - Renewal EMEA/V/C/136/R/24 (2014)2587 of 10/04/2014