Aurobindo gets 2nd MEB Netherlands okay for Mirtazapine OD Tablets

Mumbai, Oct 26 (UNI) Aurobindo Pharma has received marketing authorization approval from Medicines Evaluation Board (MEB), Netherlands for Mirtazapine 15, 30 and 45 mg orally disintegrating tablets containing the active ingredient Mirtazapine.

Announcing this, the company in a notice to BSE said this is the second formulation approval received from MEB, Netherlands for a product developed in house by the Company, and fourth such approval in Europe as a whole. With this approval, it will be easier for the Company to obtain similar marketing authorization for Mirtazapine OD tablets in the other countries of the European Union through Mutual Recognition Procedure.

Mirtazapine is a newer antidepressant that exhibits both noradrenergic and serotonergic activity. It enjoys a market of over 140 mio Euros in Europe and 90 per cent of this market is with orally disintegrating form of tablets.

The Company has already filed 20 products in various EU countries, some of which are nearing the marketing authorization approvals.

Many more filings in the EU countries are in pipeline in the coming year.

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