The Ministry of Health of the Russian Federation has registered the medicinal product Quetiapine film-coated tablets, 20 mg, 150 mg, 200 mg, 300 mg” produced by FSUE Moscow Endocrine Plant.
Marketing authorisation No. LP-005119, registration date 19/10/2018.
The specified medicinal product belongs to antipsychotic agent (neuroleptic) pharmacotherapeutic group. Indications for the use of the medicinal product are:
- Treatment of acute and chronic psychoses, including schizophrenia.
- Treatment of manic episodes in bipolar mania structure. Treatment of depressive episodes from medium to significant severity level in bipolar mania structure.
- The product is not indicated for prophylaxis of manic and depressive episodes.
The medicinal product is recommended for administration since 18 years of age.
Efficiency and safety profile has been approved by clinical studies
of comparative pharmacokinetics and bioequivalence in comparison to the reference medicinal product “Seroque® film-coated tablets, 25 mg” produced by AstraZeneka YK Ltd., Great Britain.
The Enterprise plans to release the first product commercial batches in Q1 of 2019.
Comment type is not specified in the component properties.