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FDA: Mirtazapine, marketed as Remeron/RemeronSolTab, received initial U.S. approval in 1996 for treating major depressive disorder (MDD) in adults.
EMA: In the EU, mirtazapine is indicated for major depressive episodes. Initially approved in individual Member States, its product information was harmonised through an Article 30 referral, culminating in a European Commission decision on 15 September 2008.
see also:
[Antidepressant & Major depressive disorder / Major Depression / Depressive episode (MDD…