Nexgard Spectra

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afoxolaner / milbemycin oxime

Authorised
This medicine is authorised for use in the European Union.

Overview

Nexgard Spectra is a veterinary medicine used to treat infestations with fleas, ticks, as well as demodectic and sarcoptic mange (skin infestations caused by two different types of mites) in dogs when prevention of heartworm disease (caused by a worm that infects the heart and blood vessels and is transmitted by mosquitoes), lungworm disease, eye worm and/or treatment of gut worms (hookworms, roundworms and whipworm) is also required.

Nexgard Spectra contains the active substances afoxolaner and milbemycin oxime.

This EPAR was last updated on 14/12/2021

Authorisation details

Product details
Name
Nexgard Spectra
Agency product number
EMEA/V/C/003842
Active substance
  • afoxolaner
  • milbemycin oxime
International non-proprietary name (INN) or common name
  • afoxolaner
  • milbemycin oxime
Species
Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QP54AB51
Publication details
Marketing-authorisation holder
Boehringer Ingelheim Vetmedica GmbH
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
15/01/2015
Contact address

Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Product information

14/12/2021 Nexgard Spectra - EMEA/V/C/003842 - IAIN-0032-G

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

  • Endectocides

  • Antiparasitic products, insecticides and repellents

  • milbemycin oxime, combinations

Therapeutic indication

For the treatment of flea and tick infestations in dogs when the concurrent prevention of heartworm disease (Dirofilaria immitis larvae), angiostrongylosis (reduction in level of immature adults (L5) and adults of Angiostrongylus vasorum), thelaziosis (adult Thelazia callipaeda) and/or treatment of gastrointestinal nematode infestations is indicated.

Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs for 5 weeks. 

Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) in dogs for 4 weeks.

Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.

Treatment of infestations with adult gastrointestinal nematodes of the following species: roundworms (Toxocara canis and Toxascaris leonina), hookworms (Ancylostoma caninum, Ancylostoma braziliense and Ancylostoma ceylanicum) and whipworm (Trichuris vulpis). 

Treatment of demodicosis (caused by Demodex canis). 

Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis). 

Prevention of heartworm disease (Dirofilaria immitis larvae) with monthly administration. 

Prevention of angiostrongylosis (by reduction of the level of infection with immature adult (L5) and adult stages of Angiostrongylus vasorum) with monthly administration.

Prevention of establishment of thelaziosis (adult Thelazia callipaeda eyeworm infection) with monthly administration.

Assessment history

Changes since initial authorisation of medicine

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