Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Pierre Fabre Médicament, 45, place Abel Gance, F-92100 Boulogne, France
Javlor 25 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear, colourless to pale yellow solution. |
One mL of concentrate contains 25 mg of vinflunine (as ditartrate).
One 2 mL vial contains 50 mg of vinflunine (as ditartrate).
One 4 mL vial contains 100 mg of vinflunine (as ditartrate).
One 10 mL vial contains 250 mg of vinflunine (as ditartrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Vinflunine |
Vinflunine binds to tubulin at or near to the vinca binding sites inhibiting its polymerisation into microtubules, which results in treadmilling suppression, disruption of microtubule dynamic, mitotic arrest and apoptosis. |
| List of Excipients |
|---|
|
Water for injections |
Clear type I glass vials closed by a grey butyl or black chlorobutyl rubber stopper covered with a crimped-on aluminium ring and a cap. Each vial contains either 2 mL (50 mg vinflunine), 4 mL (100 mg vinflunine) or 10 mL (250 mg vinflunine) of concentrate for solution for infusion.
Pack size of 1 and 10 vials.
Not all pack sizes may be marketed.
Pierre Fabre Médicament, 45, place Abel Gance, F-92100 Boulogne, France
EU/1/09/550/001-012
Date of first authorisation: 21 September 2009
Date of the latest renewal: 16 May 2014
| Drug | Countries | |
|---|---|---|
| JAVLOR | Austria, Brazil, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, Singapore, Turkey, United Kingdom |
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