Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Pirsue   
Auth. number : EU/2/00/027
INN : pirlimycin hydrochloride
ATC: Anatomical main group: QJ - Antiinfectives for systemic use
Therapeutic subgroup: QJ51 - Antibacterials for intramammary use
Pharmacological subgroup: QJ51F - Macrolides and lincosamides for intramammary use
Chemical subgroup: QJ51FF - Lincosamides
Chemical substance: QJ51FF90 - Pirlimycin
(See WHO ATCvet Index)
Indication: Treatment of subclinical mastitis in lactating cows due to Gram-positive cocci susceptible to pirlimycin including staphylococcal organisms such as Staphylococcus aureus, both penicillinasepositive and penicillinase-negative, and coagulase-negative staphylococci; streptococcal organisms including Streptococcus agalactiae, Streptococcus dysgalactiae and Streptococcus uberis
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
31/01/2001 Centralised - Authorisation EMEA/V/C/54 (2001)95 of 29/01/2001
15/06/2001 Centralised - Variation EMEA/V/C/54/I/1 (2001)1318 of 14/06/2001
02/10/2001 Centralised - Variation (no change in Commission Decision) EMEA/V/C/54/I/2
28/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/V/C/54/I/3
06/06/2003 Centralised - Variation EMEA/V/C/54/I/4 (2003)1844 of 04/06/2003
03/12/2003 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/54/T/5 (2003)4600 of 01/12/2003
28/01/2005 Centralised - Variation EMEA/V/C/54/IA/6
Updated with Decision(2005)3619 of 19/09/2005
21/02/2005 Centralised - Notification EMEA/V/C/54/N/7
Updated with Decision(2005)3619 of 19/09/2005
29/04/2005 Centralised - Notification EMEA/V/C/54/N/8
Updated with Decision(2005)3619 of 19/09/2005
21/09/2005 Centralised - Variation (2005)3619 of 19/09/2005
30/11/2005 Corrigendum (2005)4726 of 28/11/2005
10/02/2006 Centralised - Renewal EMEA/V/C/54/R/9 (2006)420 of 08/02/2006
03/04/2006 Centralised - Notification EMEA/V/C/54/N/10
Updated with Decision(2012)7671 of 24/10/2012
19/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/V/C/54/IA/12
18/10/2006 Centralised - Variation (no change in Commission Decision) EMEA/V/C/54/II/11
27/03/2008 Centralised - Notification EMEA/V/C/54/N/13
Updated with Decision(2012)7671 of 24/10/2012
13/04/2012 Centralised - Variation EMEA/V/C/54/IA/14
Updated with Decision(2012)7671 of 24/10/2012
26/10/2012 Centralised - Variation (2012)7671 of 24/10/2012
24/05/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/54/T/17 (2013)3112 of 22/05/2013
05/09/2013 Centralised - Variation EMEA/V/C/54/IAin/18/G
Updated with Decision(2014)6470 of 09/09/2014
11/09/2014 Centralised - Yearly update (2014)6470 of 09/09/2014