Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: BROADLINE   
Auth. number : EU/2/13/157
INN : Fipronil/ S-methoprene/ Eprinomectin/ Praziquantel
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: QP54AA54 - Eprinomectin, combinations
(See WHO ATCvet Index)
Indication: For cats with, or at risk from mixed infestations by cestodes, nematodes and ectoparasites. The veterinary medicinal product is exclusively indicated when all three groups are targeted at the same time.

Ectoparasites
- Treatment and prevention of infestations by fleas (Ctenocephalides felis). Elimination of fleas within 24 hours. One treatment prevents further infestations for at least one month.
- Prevention of environmental flea contamination by inhibiting the development of flea immature stages (eggs, larvae and pupae) for over a month.
- The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
- Treatment and prevention of infestations by ticks (Ixodes ricinus). Elimination of ticks within 48 hours. One treatment prevents further infestations for up to 3 weeks.

Cestodes
- Treatment of infestations with tapeworms (Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis).

Nematodes
- Treatment of infestations with gastrointestinal nematodes (L3, L4 larvae and adults of Toxocara cati, L4 larvae and adults of Ancylostoma tubaeforme, and adult forms of Toxascaris leonina and Ancylostoma brazilienze).
- Treatment of infestations with vesical worms (Capillaria plica).
- Prevention of heartworm disease (Dirofilaria immitis larvae) for one month.
Marketing Authorisation Holder: Merial
29 avenue Tony Garnier, F-69007 Lyon, France

  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 continues to be 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
06/12/2013 Centralised - Authorisation EMEA/V/C/2700 (2013)8901 of 04/12/2013