Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Stronghold   
Auth. number : EU/2/99/014
INN : Selamectin
ATC: Anatomical main group: QP - Antiparasitic products, insecticides and repellents
Therapeutic subgroup: QP54 - Endectocides
Pharmacological subgroup: QP54A - Macrocyclic lactones
Chemical subgroup: QP54AA - Avermectins
Chemical substance: QP54AA05 - Selamectin
(See WHO ATCvet Index)
Indication: Cats and dogs: treatment and prevention of flea infestations caused by Ctenocephalides spp. for one month following a single administration. This is as a result of the adulticidal, larvicidal and ovicidal properties of the product. The product is ovicidal for 3 weeks after administration. Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will also aid in the prevention of flea infestations in the litter up to seven weeks of age. The product can be used as part of a treatment strategy for flea allergy dermatitis and through its ovicidal and larvicidal action may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Cats and dogs: prevention of heartworm disease caused by Dirofilaria immitis with monthly administration.
STRONGHOLD may be safely administered to animals infected with adult heartworms, however, it is recommended, in accordance with good veterinary practice, that all animals 6 months of age or more living in countries where a vector exists should be tested for existing adult heartworm infections before beginning medication with STRONGHOLD. It is also recommended that dogs should be tested periodically for adult heartworm infections, as an integral part of a heartworm prevention strategy, even when Stronghold has been administered monthly. This product is not effective against adult D. immitis.
Cats and dogs: treatment of ear mites (O. cynotis).
Cats: treatment of adult roundworms (Toxocara cati) and adult intestinal hookworms (Ancylostoma tubaeforme).
Cats: treatment of biting lice infestations (Felicola subrostratus)
Dogs: treatment of biting lice infestations (Trichodectes canis)
Dogs: treatment of sarcoptic mange (caused by S. scabiei).
Dogs: treatment of adult intestinal roundworms (Toxocara canis)
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
03/12/1999 Centralised - Authorisation EMEA/V/C/50 (1999)3841 of 25/11/1999
29/05/2000 Centralised - Variation EMEA/V/C/50/I/1
19/06/2000 Centralised - Variation EMEA/V/C/50/I/2 (2000)1463 of 13/06/2000
20/11/2000 Centralised - Variation EMEA/V/C/50/II/3 (2000)3206 of 16/11/2000
06/02/2001 Centralised - Variation EMEA/V/C/50/II/4, 5 (2001)214 of 02/02/2001
31/01/2002 Centralised - Variation EMEA/V/C/50/I/6 (2002)406 of 28/01/2002
18/06/2002 Centralised - Variation EMEA/V/C/50/I/8
15/07/2002 Centralised - Variation EMEA/V/C/50/I/9 (2002)2703 of 10/07/2002
17/09/2002 Centralised - Variation EMEA/V/C/50/II/10 (2002)3405 of 11/09/2002
04/03/2004 Centralised - Variation EMEA/V/C/50/II/11 (2004)745 of 02/03/2004
27/04/2004 Centralised - Variation EMEA/V/C/50/N/12
Updated with Decision(2004)4895 of 07/12/2004
07/07/2004 Centralised - Variation EMEA/V/C/50/IB/18
Updated with Decision(2004)4895 of 07/12/2004
23/09/2004 Centralised - Variation EMEA/V/C/50/IA/14
23/09/2004 Centralised - Variation EMEA/V/C/50/IB/17
23/09/2004 Centralised - Variation EMEA/V/C/50/IA/16
23/09/2004 Centralised - Variation EMEA/V/C/50/IA/15
10/12/2004 Centralised - Renewal EMEA/V/C/50/R/13 (2004)4895 of 07/12/2004
02/03/2005 Centralised - Variation EMEA/V/C/50/IA/19
30/05/2005 Centralised - Variation EMEA/V/C/50/IA/20
02/03/2006 Centralised - Variation EMEA/V/C/50/II/21 (2006)692 of 28/02/2006
14/07/2006 Centralised - Variation EMEA/V/C/50/IA/22
Updated with Decision(2007)472 of 09/02/2007
28/09/2006 Centralised - Variation EMEA/V/C/50/IA/23
13/02/2007 Centralised - Variation (2007)472 of 09/02/2007
14/02/2007 Centralised - Variation EMEA/V/C/50/IA/24
14/02/2007 Centralised - Variation EMEA/V/C/50/IA/25
03/08/2007 Centralised - Variation EMEA/V/C/50/IA/29
03/08/2007 Centralised - Variation EMEA/V/C/50/IA/30
07/08/2007 Centralised - Variation EMEA/V/C/50/IA/29
24/08/2007 Centralised - Variation EMEA/V/C/50/IB/28
24/08/2007 Centralised - Variation EMEA/V/C/50/IB/27
24/08/2007 Centralised - Variation EMEA/V/C/50/IB/26
03/10/2007 Centralised - Variation EMEA/V/C/50/IA/31
24/01/2008 Centralised - Variation EMEA/V/C/50/IA/33
20/03/2008 Centralised - Variation EMEA/V/C/50/II/32 (2008)1174 of 18/03/2008
17/12/2008 Centralised - Variation EMEA/V/C/50/IA/35
23/02/2009 Centralised - Variation EMEA/V/C/50/II/34
05/10/2009 Centralised - Renewal EMEA/V/C/50/R/36 (2009)7663 of 01/10/2009
03/11/2009 Centralised - Variation EMEA/V/C/50/IA/37
23/12/2009 Centralised - Variation EMEA/V/C/50/IB/38
22/04/2010 Centralised - Variation EMEA/V/C/50/IA/39
21/09/2010 Centralised - Variation EMEA/V/C/50/IA/40
14/09/2012 Centralised - Variation EMEA/V/C/50/IB/43
Updated with Decision(2012)7707 of 25/10/2012
29/10/2012 Centralised - Variation (2012)7707 of 25/10/2012
24/05/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/50/T/44 (2013)3111 of 22/05/2013
05/09/2013 Centralised - Variation EMEA/V/C/50/IAin/45/G