Activyl

indoxacarb

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This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

What is Activyl?

Activyl is a medicine that contains the active substance indoxacarb. It is available as a clear, colourless to yellow solution presented as a ‘spot-on’ in pipettes already filled with the correct amount of Activyl needed to treat one cat or dog depending on its weight (five sizes of pipette for different dog weights and two sizes of pipette for different cat weights).

What is Activyl used for?

Activyl is used to treat and prevent flea infestations in dogs and cats and to treat flea-allergy dermatitis (an allergic reaction to flea bites). Activyl is given as a single treatment.

The contents of one full Activyl pipette (appropriate to the animal and its weight) is applied directly to the skin, after parting the animals fur, onto the back of the cat’s neck at the base of its head, or between the shoulder blades and along the back of dogs.

How does Activyl work?

The active substance in Activyl, indoxacarb, is an ectoparasiticide. This means that it will kill parasites that live on the skin or in the fur of animals, such as fleas. After application, indoxacarb is eaten by the insects and activated in their gut into an active compound. This active compound interferes with the parasites’ nervous system and causes paralysis and death.

How has Activyl been studied?

Data were provided on the pharmaceutical quality, the tolerance of the products in cats and dogs, the safety in humans (people in contact with the product) and the safety to the environment.

The effectiveness against the specified parasites was investigated in both laboratory studies and in five field studies (four for the spot-on for cats or dogs only and one for both cats and dogs). In the main field study, dogs and cats of various breeds, age groups, genders and weights were treated either with Activyl or fipronil, another spot-on medicine which is authorised in the European Union for this indication. The effectiveness was measured by counting fleas, flea-allergy-dermatitis assessment and observations of local reactions at the application site after treatment.

What benefit has Activyl shown during the studies?

The results from the laboratory studies and from the field studies, in both cats and dogs, showed that Activyl is as effective as the comparator medicine. A reduction in symptoms of flea-allergy dermatitis was recorded in both target species. Efficacy against flea infestations of more than 95% was achieved in dogs by 14 days post-treatment and in cats by 42 days post-treatment in the study. The studies also showed that Activyl helps with the management of allergic flea dermatitis.

What is the risk associated with Activyl?

Dogs and cats might salivate after treatment. This is thought to be the result of licking the application site straight after treatment. There might also be some temporary itchiness, inflammation or hair loss at the place where the product has been applied to the skin. These signs disappear without further treatment.

Activyl should not be allowed to enter surface water, as it may be harmful for aquatic organisms.

For a full list of all side effects reported with Activyl, see the package leaflet.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Pet owners should avoid skin contact with the pipette contents. They should not smoke, eat or drink, and should wash their hands thoroughly after use. If accidental exposure occurs, the eyes should be rinsed with water or the skin washed with soap and water. The product should be kept away from heat, sparks, open flames or other sources of ignition.

Animals should not be stroked, groomed or allow to groom each other, until the application site is dry, and they should not be allowed to swim or treated with shampoo within 48 hours after treatment. Care should be taken to ensure that the content of the pipette should not come into contact with the eyes of the recipient or other animals.

Why has Activyl been approved?

The CVMP concluded that the benefits of Activyl exceed the risks for the treatment and prevention of flea infestations in dogs and cats. Furthermore, the CVMP concluded that the product is effective as part of a treatment strategy for flea-allergy dermatitis and recommended that Activyl be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Activyl

The European Commission granted a marketing authorisation valid throughout the European Union for Activyl to Intervet International BV on 18 February 2011. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
Activyl : EPAR - Summary for the public BG = bălgarski 28/02/2011  
Activyl : EPAR - Summary for the public ES = español 28/02/2011  
Activyl : EPAR - Summary for the public CS = čeština 28/02/2011  
Activyl : EPAR - Summary for the public DA = dansk 28/02/2011  
Activyl : EPAR - Summary for the public DE = Deutsch 28/02/2011  
Activyl : EPAR - Summary for the public ET = eesti keel 28/02/2011  
Activyl : EPAR - Summary for the public EL = elliniká 28/02/2011  
Activyl : EPAR - Summary for the public EN = English 28/02/2011  
Activyl : EPAR - Summary for the public FR = français 28/02/2011  
Activyl : EPAR - Summary for the public IT = italiano 28/02/2011  
Activyl : EPAR - Summary for the public LV = latviešu valoda 28/02/2011  
Activyl : EPAR - Summary for the public LT = lietuvių kalba 28/02/2011  
Activyl : EPAR - Summary for the public HU = magyar 28/02/2011  
Activyl : EPAR - Summary for the public MT = Malti 28/02/2011  
Activyl : EPAR - Summary for the public NL = Nederlands 28/02/2011  
Activyl : EPAR - Summary for the public PL = polski 28/02/2011  
Activyl : EPAR - Summary for the public PT = português 28/02/2011  
Activyl : EPAR - Summary for the public RO = română 28/02/2011  
Activyl : EPAR - Summary for the public SK = slovenčina 28/02/2011  
Activyl : EPAR - Summary for the public SL = slovenščina 28/02/2011  
Activyl : EPAR - Summary for the public FI = suomi 28/02/2011  
Activyl : EPAR - Summary for the public SV = svenska 28/02/2011  

This EPAR was last updated on 01/04/2014 .

Authorisation details

Product details

Product details for Activyl
NameActivyl
Agency product numberEMEA/V/C/000163
Active substance

indoxacarb

International non-proprietary name (INN) or common name

indoxacarb

Species DogsCats
Anatomical therapeutic chemical veterinary (ATCvet) codeQP53AX27

Publication details

Publication details for Activyl
Marketing-authorisation holder

Intervet International BV

Revision4
Date of issue of marketing authorisation valid throughout the European Union18/02/2011

Contact address:

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Netherlands

Product information

Product information

06/03/2014  Activyl -EMEA/V/C/000163 -IB/0005

Name Language First published Last updated
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014
Activyl : EPAR - Product Information SV = svenska 28/02/2011 01/04/2014

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012
Activyl : EPAR - All Authorised presentations SV = svenska 28/02/2011 23/02/2012

Pharmacotherapeutic group

Antiparasitic products, insecticides and repellents

Therapeutic indication

Treatment and prevention of flea infestation.

For dogs and cats: Treatment and prevention of flea infestation.

The veterinary medicinal product can be used as part of a treatment strategy for flea-allergy dermatitis. Developing stages of fleas in the pet's immediate surroundings are killed following contact with Activyl-treated pets.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Activyl : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 23/02/2012 01/04/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Activyl : EPAR - Scientific Discussion SV = svenska 28/02/2011  
CVMP summary of positive opinion for Activyl SV = svenska 10/12/2010