Javlor

vinflunine

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This is a summary of the European public assessment report (EPAR) for Javlor. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Javlor.

What is Javlor?

Javlor is a concentrate for solution for infusion (drip into a vein). It contains the active substance vinflunine (25 mg/l).

What is Javlor used for?

Javlor is used for the treatment of adults with advanced or metastatic ‘transitional-cell carcinoma of the urothelial tract’ (a cancer that affects the lining of the bladder and the rest of the urinary tract). ‘Metastatic’ means that the cancer has spread to other parts of the body. Javlor is used when previous treatment with a platinum-containing anticancer medicine has failed.

The medicine can only be obtained with a prescription.

How is Javlor used?

Treatment with Javlor should be started under the supervision of a doctor qualified to use anticancer medicines and is only given in specialised hospital units. Before administering Javlor, patients should have a blood test to check their blood-cell and haemoglobin levels. This is because low levels of haemoglobin (a protein found in red blood cells that carries oxygen around the body) and blood cells (white blood cells and platelets) are a frequent side effect of the medicine.

The dose of Javlor to be given is based on the patient’s body surface area (calculated using height and weight). The recommended dose is 320 mg per m2. Javlor is given as a drip into a vein over a period of 20 minutes once every three weeks. The doctor may need to adjust the dose by taking into account the patient’s age, liver or kidney function and certain side effects that the patient may be experiencing. The doctor may also delay or stop doses if the patient experiences certain side effects, including low levels of platelets and neutrophils (a type of white blood cell), and certain side effects affecting the heart, liver or lungs. Measures to prevent constipation, such as laxatives, are recommended after Javlor is given in the first week. 

For more information, see the summary of product characteristics (also part of the EPAR).

How does Javlor work?

The active substance in Javlor, vinflunine, belongs to the group of anticancer medicines known as the vinca alkaloids. It attaches to a protein in cells called ‘tubulin’, which is important in the formation of the internal ‘skeleton’ that cells need to assemble when they divide. By attaching to tubulin in cancer cells, vinflunine stops the formation of the skeleton, preventing the division and spread of the cancer cells.

How has Javlor been studied?

In one main study of 370 adults with advanced or metastatic transitional-cell carcinoma of the urothelial tract, patients who were given Javlor treatment were compared with patients who were not given any anticancer medicine. During the study all patients received best supportive care (any medicines or techniques to help patients, but not other anticancer medicines). All the patients had previously received treatment with a platinum-containing medicine which failed. The main measure of effectiveness was how long the patients lived. The study also looked separately at the results in eligible patients who fulfilled strict criteria such as having had a worsening of the disease after treatment with a platinum-containing medicine.

What benefit has Javlor shown during the studies?

Javlor with best supportive care was more effective than best supportive care alone in prolonging the lives of patients with advanced or metastatic transitional-cell carcinoma of the urothelial tract. Among all patients in the study, there was no clear evidence of a difference in survival between patients who received Javlor and those who did not. However, there was a difference among patients who fulfilled the strict criteria entry requirements for the study. In this group, those given Javlor lived for 6.9 months compared with 4.3 months for patients who were not given the Javlor.

What is the risk associated with Javlor?

The most common side effects with Javlor (seen in more than 1 patient in 10) are neutropenia, leucopenia (low white-blood-cell counts), anaemia (low red-blood-cell counts), thrombocytopenia (low platelet counts), loss of appetite, constipation, abdominal (stomach) pain, vomiting, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), diarrhoea, alopecia (hair loss), myalgia (muscle pain), asthenia (weakness) or fatigue (tiredness), injection-site reactions, fever and weight loss. For the full list of all side effects reported with Javlor, see the package leaflet.

Javlor must not be used in people who are hypersensitive (allergic) to vinflunine or other vinca alkaloids. It must not be used in patients who have or have had a severe infection within the past two weeks or in patients with a neutrophil count of less than 1,500 per mm3 for the first administration or less than 1,000 per mm3 for subsequent administrations, or a platelet count less than 100,000 per mm3. It must also not be used in breastfeeding mothers.

Why has Javlor been approved?

The CHMP decided that Javlor’s benefits are greater than its risks and recommended that Javlor be given marketing authorisation.

Other information about Javlor

The European Commission granted a marketing authorisation valid throughout the European Union for Javlor on 21 September 2009.

For more information about treatment with Javlor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Javlor : EPAR - Summary for the public BG = bălgarski 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public ES = español 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public CS = čeština 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public DA = dansk 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public DE = Deutsch 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public ET = eesti keel 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public EL = elliniká 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public EN = English 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public FR = français 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public IT = italiano 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public LV = latviešu valoda 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public LT = lietuvių kalba 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public HU = magyar 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public MT = Malti 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public NL = Nederlands 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public PL = polski 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public PT = português 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public RO = română 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public SK = slovenčina 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public SL = slovenščina 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public FI = suomi 2009-10-08 2013-08-29
Javlor : EPAR - Summary for the public SV = svenska 2009-10-08 2013-08-29

This EPAR was last updated on 10/12/2014 .

Authorisation details

Product details

Product details for Javlor
NameJavlor
Agency product numberEMEA/H/C/000983
Active substance

vinflunine

International non-proprietary name (INN) or common name

vinflunine

Therapeutic area Carcinoma, Transitional CellUrologic Neoplasms
Anatomical therapeutic chemical (ATC) code L01CA05

Publication details

Publication details for Javlor
Marketing-authorisation holder

Pierre Fabre Médicament

Revision7
Date of issue of marketing authorisation valid throughout the European Union21/09/2009

Contact address:

Pierre Fabre Médicament
45, place Abel Gance
F-92100 Boulogne
France

Product information

Product information

19/06/2014  Javlor -EMEA/H/C/000983 -PSUV/0015

Name Language First published Last updated
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30
Javlor : EPAR - Product Information SV = svenska 2009-10-08 2014-07-30

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
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  
Javlor : EPAR - All Authorised presentations SV = svenska 2009-10-08  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional-cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen.

Efficacy and safety of vinflunine have not been studied in patients with performance status ≥ 2.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Javlor : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2011-02-08 2014-07-30
Javlor-H-C-983-II-11: EPAR - Refusal assessment report - Variation SV = svenska 2014-12-10  
Javlor-H-C-983-II-11 : EPAR - Scientific conclusions and grounds for refusal of the variation presented by the European Medicines Agency SV = svenska 2014-12-10  
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) SV = svenska 2014-09-26 2014-12-10
Javlor-H-C-983-PSUV-15 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-07-30  

Initial marketing-authorisation documents

Name Language First published Last updated
Javlor : EPAR - Public assessment report SV = svenska 2009-10-08  
Committee for medicinal products for human use, summary of positive opinion for Javlor SV = svenska 2009-06-25  

Authorised

This medicine is approved for use in the European Union