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They are marketed in all European Union (EU) Member States under various trade names including Depakine/Deprakine, Depakote and Epilim, and as generic medicines.On 15 April 2008, the company that markets Valproat Ratiopharm Chrono, a generic medicine containing valproate used as anti-epileptic, applied to the German medicines regulatory agency to extend its use to include the ‘acute treatment of manic episode and prevention of recurrence in patients with bipolar disorder’.This extension was in line with the reference medicine on which the generic medicine is based.However, on 9 March 2009, the Dutch medicines regulatory agency raised an objection to this change2.The concern was that the data presented to support this use were too limited.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of valproate in this condition outweigh their risks, and that all marketing authorisations for medicines containing valproate throughout Europe should be amended to include the treatment of manic episodes in bipolar disorders when lithium is contraindicated or not tolerated.
The review was carried out under an ‘Article 31’ referral Valproate is a salt (sodium or semisodium) of valproic acid, an anti-epileptic medicine which can also be used in patients with bipolar disorder.
This is a mental illness causing alternating periods of high mood (mania) and depression.
The exact way valproic acid works is not fully understood, but it is known to increase the activity of the neurotransmitter gamma-amino butyric acid (GABA), by increasing the amount of GABA available in the gaps between nerve cells.
Neurotransmitters are chemicals that allow nerve cells to communicate with each other.