Palladia

toceranib

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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 Palladia?

Palladia contains toceranib, which belongs to a class of medicines with anticancer activity. It is available as tablets: 10 mg (blue), 15 mg (orange) and 50 mg (red).

What is Palladia used for?

Palladia is used to treat dogs with mast-cell tumours (a type of skin cancer). It is used for tumours that are severe in character (grade 2 or 3), have come back, and cannot be removed with surgery. The usual dose is 3.25 mg per kilogram bodyweight, and the number of tablets to use is carefully calculated for each dog. The tablets are given every other day, with or without food. The duration of treatment depends on the dog’s response to treatment.

How does Palladia work?

The active substance in Palladia, toceranib, is a receptor-tyrosine-kinase inhibitor. This means that it blocks some specific enzymes known as tyrosine kinases. These enzymes can be found in mast-cell tumours, where they are involved in the growth and spread of cancer cells, and the growth of blood vessels. By blocking these enzymes, Palladia can help to control abnormal cell growth and prevent further development of this type of tumour.

How has Palladia been studied?

A number of studies with Palladia were carried out either in laboratory dogs or in animal patients in veterinary practices or hospitals.

The main study was carried out in two phases in 151 dogs with mast-cell tumours. In a first phase (up to six weeks), Palladia was compared with placebo (a dummy treatment). If the disease was getting worse, treatment with Palladia was stopped and the dog was taken out of the study. After six weeks (second phase), the study continued with all the remaining dogs receiving Palladia for an average of another four and a half months.

Treatment started with the recommended dose, but this dose was later reduced or treatment interrupted for a few days in some dogs. The main measures of effectiveness were the ‘objective response’ (an evaluation by the veterinarian of the way the tumour changed during treatment) and the time taken until the tumour started to get worse.

What benefit has Palladia shown during the studies?

Dogs treated with Palladia had greater objective response rates (37%) than dogs treated with placebo (8%) after six weeks of treatment. A complete response (disappearance of the tumour) was seen in around 8% and a partial response (shrinkage of the tumour) was seen in around 29% of the dogs treated with Palladia.

For Palladia-treated dogs, it also took longer for the tumour to get worse (nine to ten weeks on average) than in those receiving placebo (three weeks on average).

What is the risk associated with Palladia?

The most common side effects with Palladia are diarrhoea and vomiting, loss of appetite, lethargy (lack of energy), neutropenia (low white-blood-cell counts), difficulty moving (lameness) and weight loss. These reactions are usually mild to moderate and temporary. Dogs should be regularly monitored for side effects by the veterinarian (at the beginning of treatment, this should be at least once per week). In case of side effects, the veterinarian might decide to lower the dose of Palladia or to stop treatment, either temporarily or permanently.

Palladia must not be used in dogs less than two years of age or weighing less than 3 kilograms, in bitches that are pregnant or lactating, or in dogs intended for breeding. It should not be used in dogs that may be hypersensitive (allergic) to toceranib or any of the other ingredients. It must not be used in dogs with bleeding in the stomach or gut. For a full list of all side effects or precautions, see the package leaflet.

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

The tablets must be given whole and should not be divided, broken or ground up. If broken tablets, or the vomit, urine or faeces of a treated dog comes into contact with the skin or eyes, rinse immediately with plenty of water. Children should not have close contact with the medicine, or with the faeces or vomit of treated dogs. If Palladia is taken accidentally, seek medical advice immediately and show the package leaflet or the label to the doctor. For more information, see the package leaflet.

Why has Palladia been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Palladia exceed the risks for the treatment of non-resectable Patnaik grade-II (intermediate-grade) or -III (high-grade), recurrent, cutaneous mast-cell tumours in dogs and recommended that Palladia be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Palladia

The European Commission granted a marketing authorisation valid throughout the European Union for Palladia on 23 September 2009. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
Palladia : EPAR - Summary for the public BG = bălgarski 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public ES = español 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public CS = čeština 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public DA = dansk 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public DE = Deutsch 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public ET = eesti keel 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public EL = elliniká 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public EN = English 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public FR = français 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public IT = italiano 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public LV = latviešu valoda 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public LT = lietuvių kalba 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public HU = magyar 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public MT = Malti 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public NL = Nederlands 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public PL = polski 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public PT = português 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public RO = română 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public SK = slovenčina 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public SL = slovenščina 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public FI = suomi 2009-10-01 2013-06-05
Palladia : EPAR - Summary for the public SV = svenska 2009-10-01 2013-06-05

This EPAR was last updated on 11/04/2017 .

Authorisation details

Product details

Product details for Palladia
NamePalladia
Agency product numberEMEA/V/C/000150
Active substance

toceranib

International non-proprietary name (INN) or common name

toceranib

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes QL01XE91







Publication details

Publication details for Palladia
Marketing-authorisation holder

Zoetis Belgium SA

Revision7
Date of issue of marketing authorisation valid throughout the European Union23/09/2009

Contact address:

Zoetis Belgium SA
Rue Laid Burnait, 1
1348 Louvain-la-Neuve
Belgium

Product information

Product information

23/03/2017  Palladia -EMEA/V/C/000150 -IG/0747

Name Language First published Last updated
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11
Palladia : EPAR - Product Information SV = svenska 2009-10-02 2017-04-11

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
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  
Palladia : EPAR - All Authorised presentations SV = svenska 2009-10-01  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Treatment of non-resectable Patnaik grade-II (intermediate-grade) or -III (high-grade), recurrent, cutaneous mast-cell tumours in dogs.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Palladia : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2010-06-03 2017-04-11

Initial marketing-authorisation documents