Comfortis

spinosad

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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 Comfortis?

Comfortis is a veterinary medicine that contains spinosad. It is available as chewable tablets in five strengths (90 mg, 140 mg, 180 mg, 270 mg, 425 mg) for dogs and cats and in three additional strengths for larger dogs (665 mg, 1040 mg and 1620 mg).

What is Comfortis used for?

Comfortis is used to treat and prevent flea infestations in dogs and cats. Comfortis can also be used as part of a treatment strategy for flea allergic dermatitis (an allergic reaction to flea bites).

Comfortis is given as a single dose which can be repeated every month. The appropriate strength tablet(s) should be used according to the dog’s or cat’s weight (the dose differs between dogs and cats).

How does Comfortis work?

The active substance in Comfortis, spinosad, is an insecticide which works by interfering with certain receptors (nicotinic acetylcholine receptors) in the fleas’ nervous system, which results in their subsequent paralysis and death. The medicine starts killing fleas on the dog or cat 30 minutes after giving the tablet(s) and it remains active for up to four weeks.

How has Comfortis been studied?

Comfortis has been studied in laboratory animals, as well as in dogs or cats that were treated in various veterinary practices and clinics across Europe (“clinical studies”).

Laboratory studies were carried out to look at the effectiveness of Comfortis in killing the fleas on dogs and cats with existing flea infestations, and at the speed of killing fleas on the treated animals.

In the clinical studies, Comfortis was compared with a veterinary medicine authorised in the EU for the treatment and prevention of flea infestations (selamectin, a ‘spot-on’ applied to the skin of the dog or cat). The studies involved dogs and cats of different age groups, genders, breeds and weights. The effectiveness of the product was measured by looking at the number of fleas that were alive at various times after treatment.

What benefit has Comfortis shown during the studies?

The results of laboratory studies demonstrated that the product was effective at killing the fleas on dogs or cats with existing flea infestations within 24 hours after treatment.

Comparative studies on fed/fasted dogs indicated that Comfortis tablets should be given with a meal to increase the amount of the active substance absorbed by the dog. Similarly Comfortis tablets should be given with a meal or immediately after feeding in cats.

The clinical studies, carried out for between one and three months, showed that Comfortis is as effective as the comparator medicine in the treatment of flea infestations in dogs and cats. The studies also showed that the preventive effect of spinosad against new flea infestations (which results from its residual insecticidal activity) lasts for up to 4 weeks.

Studies also showed that the frequency and severity of flea allergy dermatitis (an allergic reaction to flea bites) is significantly decreased in dogs and cats treated with Comfortis and so its use as part of a treatment strategy for the control of this condition is justified.

What is the risk associated with Comfortis?

The most common side effect is vomiting, which is mild and transient in most dogs and cats. Other common side effects in cats include diarrhoea and loss of appetite. For a full list of all side effects reported with Comfortis, see the package leaflet.

Comfortis tablets must not be used in dogs or cats aged less than 14 weeks, or in dogs or cats that are hypersensitive (allergic) to spinosad or any of the other ingredients in the tablets.

Comfortis tablets are not recommended for use in dogs weighing less than 1.3 kg or in cats weighing less than 1.2 kg (as accurate dosing of the product in such small dogs or cats is not possible and they may be accidentally overdosed).

Use of Comfortis tablets in dogs or cats which have epilepsy may involve additional risks.

The safety of Comfortis has not been sufficiently established in dogs or cats that are pregnant or breeding (male or female). The safety for suckling puppies or kittens has not been sufficiently established, therefore Comfortis should only be used in breeding, pregnant or lactating dogs or cats if the veterinary surgeon has specifically recommended it.

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

People who give the medicine should wash their hands after handling Comfortis.

Accidental ingestion, including by children, may cause adverse reactions. In case of accidental ingestion, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.

Why has Comfortis been approved?

The CVMP concluded that the benefits of Comfortis outweigh the risks when used for the approved indications and recommended that Comfortis be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Comfortis:

The European Commission granted a marketing authorisation valid throughout the European Union, for Comfortis on 11/02/2011. Information on the prescription status of this product may be found on the label/outer package.

Name Language First published Last updated
Comfortis : EPAR - Summary for the public BG = bălgarski 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public ES = español 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public CS = čeština 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public DA = dansk 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public DE = Deutsch 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public ET = eesti keel 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public EL = elliniká 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public EN = English 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public FR = français 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public IT = italiano 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public LV = latviešu valoda 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public LT = lietuvių kalba 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public HU = magyar 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public MT = Malti 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public NL = Nederlands 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public PL = polski 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public PT = português 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public RO = română 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public SK = slovenčina 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public SL = slovenščina 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public FI = suomi 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public SV = svenska 2011-08-22 2013-12-05
Comfortis : EPAR - Summary for the public HR = Hrvatski 2011-08-22 2013-12-05

This EPAR was last updated on 27/01/2016 .

Authorisation details

Product details

Product details for Comfortis
NameComfortis
Agency product numberEMEA/V/C/002233
Active substance

spinosad

International non-proprietary name (INN) or common name

spinosad

Species DogsCats
Anatomical therapeutic chemical veterinary (ATCvet) codeQP53BX03

Publication details

Publication details for Comfortis
Marketing-authorisation holder

Eli Lilly and Company Limited

Revision5
Date of issue of marketing authorisation valid throughout the European Union11/02/2011

Contact address:

Eli Lilly and Company Limited
Lilly House
Priestley Road
Basingstoke
Hampshire
RG24 9NL
United Kingdom

Product information

Product information

07/01/2016  Comfortis -EMEA/V/C/002233 -R/0015

Name Language First published Last updated
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27
Comfortis : EPAR - Product Information HR = Hrvatski 2011-08-22 2016-01-27

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
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05
Comfortis : EPAR - All Authorised presentations HR = Hrvatski 2011-08-22 2013-12-05

Pharmacotherapeutic group

Other active parasiticides for systemic use

Therapeutic indication

Treatment and prevention of flea infestations (Ctenocephalides felis).

The preventive effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for up to 4 weeks after a single administration of the product.

The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Comfortis : EPAR - Scientific Discussion HR = Hrvatski 2011-08-22  
CVMP summary of positive opinion for Comfortis HR = Hrvatski 2010-12-10