Information letter from 09.11.2021 № 01I-1463/21 On the results of state quality control of the drug “Amiodarone”

2021-11-23T13:33:05+03:00

Federal Service for Surveillance in Healthcare reports information about the detection of the drug "AMIODARON, concentrate for preparation of solution for intravenous injection 50 mg/ml 3 ml, ampoules (10), packs of cartons, series 080519 manufactured by Ellara LLC (Russia), which quality does not meet the requirements of the regulatory documentation for the indicator "related impurities" [...]

Information letter from 09.11.2021 № 01I-1463/21 On the results of state quality control of the drug “Amiodarone”2021-11-23T13:33:05+03:00

Amiodarone – Scientific findings and reasons for changing the conditions of the marketing authorization – PSUSA-00000166-202012

2021-11-08T17:12:39+03:00

In view of the available data found in the literature and spontaneous reports, including those describing the chronology of drug interactions between Amiodarone and Sirolimus, leading to increased toxicity of Sirolimus, PRAC considers the estimated cumulative data to be sufficient to support a causal relationship. The PRAC concluded that the information on products containing Amiodarone [...]

Amiodarone – Scientific findings and reasons for changing the conditions of the marketing authorization – PSUSA-00000166-2020122021-11-08T17:12:39+03:00

Information letter dated 15.10.2021 No. 02I-1362/21 On the results of state quality control of the medicinal product

2021-10-29T17:00:56+03:00

The Federal Service for Surveillance in Healthcare informs about the receipt of the information on the detection within the framework of inspections for federal state control (supervision) in the field of drug circulation FGBU "Information and Methodological Center for Expertise, Accounting and Analysis of the Circulation of Medical Products" of Roszdravnadzor (Khabarovsk branch) drug "Amiodarone, [...]

Information letter dated 15.10.2021 No. 02I-1362/21 On the results of state quality control of the medicinal product2021-10-29T17:00:56+03:00
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