Javlor

vinflunine

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

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.

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

: 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.

: 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).

: 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.

: 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.

: 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.

: 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.

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

: 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.

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Javlor : EPAR - Summary for the public (PDF/57.21 KB)

First published: 08/10/2009
Last updated: 29/08/2013
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  (PDF/157.63 KB)
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- Hungarian
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- Italian
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- Latvian
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- Lithuanian
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- Maltese
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- Polish
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  (PDF/117.79 KB)
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- Swedish
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Javlor : EPAR - Risk management plan summary (PDF/76.26 KB)

First published: 23/11/2022

This EPAR was last updated on 23/11/2022

Authorisation details

Product details
Name	Javlor
Agency product number	EMEA/H/C/000983
Active substance	vinflunine
International non-proprietary name (INN) or common name	vinflunine
Therapeutic area (MeSH)	Carcinoma, Transitional Cell Urologic Neoplasms
Anatomical therapeutic chemical (ATC) code	L01CA05

Publication details
Marketing-authorisation holder	Pierre Fabre Medicament
Revision	10
Date of issue of marketing authorisation valid throughout the European Union	21/09/2009
Contact address	Pierre Fabre Medicament Les Cauquillous 81500 - Lavaur France

Product information

07/11/2022 Javlor - EMEA/H/C/000983 - IB/0024

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Javlor : EPAR - Product Information (PDF/408.44 KB)

First published: 08/10/2009
Last updated: 09/02/2022
- Bulgarian
  (PDF/536.61 KB)
- Croatian
  (PDF/471.42 KB)
- Czech
  (PDF/480.63 KB)
- Danish
  (PDF/414.36 KB)
- Dutch
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- Estonian
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- Finnish
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- French
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- German
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- Greek
  (PDF/533.89 KB)
- Hungarian
  (PDF/528.83 KB)
- Icelandic
  (PDF/370.42 KB)
- Italian
  (PDF/466.59 KB)
- Latvian
  (PDF/540 KB)
- Lithuanian
  (PDF/491.89 KB)
- Maltese
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- Norwegian
  (PDF/431.51 KB)
- Polish
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- Portuguese
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- Romanian
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- Slovak
  (PDF/471.63 KB)
- Slovenian
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- Spanish
  (PDF/419.69 KB)
- Swedish
  (PDF/424.15 KB)

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

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.

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Javlor : EPAR - All Authorised presentations (PDF/16.9 KB)

First published: 08/10/2009
Last updated: 08/10/2009
- Bulgarian
  (PDF/84.68 KB)
- Croatian
  (PDF/28.87 KB)
- Czech
  (PDF/83.69 KB)
- Danish
  (PDF/17.81 KB)
- Dutch
  (PDF/16.7 KB)
- Estonian
  (PDF/17.78 KB)
- Finnish
  (PDF/17.68 KB)
- French
  (PDF/16.55 KB)
- German
  (PDF/17.96 KB)
- Greek
  (PDF/80.36 KB)
- Hungarian
  (PDF/46.83 KB)
- Italian
  (PDF/17.27 KB)
- Latvian
  (PDF/85.97 KB)
- Lithuanian
  (PDF/83.29 KB)
- Maltese
  (PDF/86.4 KB)
- Polish
  (PDF/88.14 KB)
- Portuguese
  (PDF/16.81 KB)
- Romanian
  (PDF/81.63 KB)
- Slovak
  (PDF/80.89 KB)
- Slovenian
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- Spanish
  (PDF/17.33 KB)
- Swedish
  (PDF/17.09 KB)

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

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Javlor : EPAR - Procedural steps taken and scientific information after authorisation (PDF/145.07 KB)

First published: 08/02/2011
Last updated: 23/11/2022
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Javlor-H-C-983-II-11: EPAR - Refusal assessment report - Variation (PDF/747.64 KB)

Adopted

First published: 10/12/2014
Last updated: 10/12/2014
EMA/619399/2014
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Javlor-H-C-983-II-11 : EPAR - Scientific conclusions and grounds for refusal of the variation presented by the European Medicines Agency (PDF/34.33 KB)

First published: 10/12/2014
Last updated: 10/12/2014
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Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) (PDF/74.28 KB)

Adopted

First published: 26/09/2014
Last updated: 10/12/2014
EMA/587197/2014
- Bulgarian
  (PDF/100.09 KB)
- Croatian
  (PDF/92 KB)
- Czech
  (PDF/95.93 KB)
- Danish
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- Dutch
  (PDF/74.46 KB)
- Estonian
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- Finnish
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- French
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- German
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- Greek
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- Hungarian
  (PDF/90.28 KB)
- Italian
  (PDF/67.66 KB)
- Latvian
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- Lithuanian
  (PDF/95.85 KB)
- Maltese
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- Polish
  (PDF/97.74 KB)
- Portuguese
  (PDF/73.4 KB)
- Romanian
  (PDF/93.71 KB)
- Slovak
  (PDF/95.21 KB)
- Slovenian
  (PDF/90.88 KB)
- Spanish
  (PDF/73.66 KB)
- Swedish
  (PDF/73.44 KB)
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Javlor-H-C-983-PSUV-15 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/74.57 KB)

First published: 30/07/2014
Last updated: 30/07/2014
EMEA/H/C/000983/PSUV/0015

Initial marketing-authorisation documents

News

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 September 2014

26/09/2014

Javlor

Table of contents

Overview

Javlor : EPAR - Summary for the public (PDF/57.21 KB)

Javlor : EPAR - Risk management plan summary (PDF/76.26 KB)

Authorisation details

Product information

Javlor : EPAR - Product Information (PDF/408.44 KB)

Javlor : EPAR - All Authorised presentations (PDF/16.9 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Javlor : EPAR - Procedural steps taken and scientific information after authorisation (PDF/145.07 KB)

Javlor-H-C-983-II-11: EPAR - Refusal assessment report - Variation (PDF/747.64 KB)

Javlor-H-C-983-II-11 : EPAR - Scientific conclusions and grounds for refusal of the variation presented by the European Medicines Agency (PDF/34.33 KB)

Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) (PDF/74.28 KB)

Javlor-H-C-983-PSUV-15 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/74.57 KB)

Initial marketing-authorisation documents

Javlor : EPAR - Public assessment report (PDF/2.16 MB)

Committee for medicinal products for human use, summary of positive opinion for Javlor (PDF/33.18 KB)

News

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