About Елена Матвеева

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So far Елена Матвеева has created 355 blog entries.

Glatiramer – Scientific Conclusions and Basis for Modification of Registration Approval Terms – PSUSA-00001529-202011

2021-11-23T13:45:51+03:00

In view of the available evidence of severe liver damage from clinical trials and spontaneous reports, including in some cases a close temporal relationship, positive withdrawal, and/or re-challenge, PRAC believes that a causal relationship between glatiramer and severe liver damage has been established. . PRAC concluded that the information about products containing glatiramer should be [...]

Glatiramer – Scientific Conclusions and Basis for Modification of Registration Approval Terms – PSUSA-00001529-2020112021-11-23T13:45:51+03:00

Information letter No. 01I-1468/21 of 09.11.2021 on introduction of new safety info into the instruction for use of the drug Baeta® (INN – Exenatide)

2021-11-23T13:34:52+03:00

New data on the efficacy and safety of the drug were obtained, therefore significant changes were made to the Instructions for Medical Use (SMPC), including the sections Pharmacodynamics, Pharmacokinetics, Indications for use, Use during pregnancy and breastfeeding, Dosage and administration, Side effects, Overdose, Interaction with other drugs, Special Precautions, the section "Effect on the ability [...]

Information letter No. 01I-1468/21 of 09.11.2021 on introduction of new safety info into the instruction for use of the drug Baeta® (INN – Exenatide)2021-11-23T13:34:52+03:00

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

Ministry of Health extends increased prices for lomustine and azathioprine

2021-11-22T13:50:34+03:00

From November 17, 2021, the Ministry of Health extended the prices of the anticancer drug lomustine and the immunosuppressant azathioprine increased by the Government Decree № 1771 from 31.10.2020. This follows from the State Register of Drug Prices. The prices, which are 3.4 times higher than the regular VED cost for lomustine and 71% for [...]

Ministry of Health extends increased prices for lomustine and azathioprine2021-11-22T13:50:34+03:00

Audit with LLC “Zavod Medsintez”, 29.06.2021

2021-11-19T14:16:05+03:00

On 29.06.2021 ANO NSC of Pharmacovigilance together with "Zavod Medsintez" LLC conducted an audit*, the scope of which was critical processes of pharmacovigilance. Medsintez pharma plant specializes in the production of pharmaceutical products and devices The company produces infusion solutions, finished dosage forms and human insulin substances, solid and liquid dosage forms. "Medsintez" is one [...]

Audit with LLC “Zavod Medsintez”, 29.06.20212021-11-19T14:16:05+03:00

A total of 4 billion doses of COVID-19 vaccines have been used worldwide

2021-11-19T14:09:43+03:00

More than 4 billion doses of coronavirus vaccines have been used cumulatively worldwide since immunization programs began, MedicalXpress reports. The rate of vaccination has slowed a bit recently: the last, fourth billion doses were used in 30 days, whereas previously it took 26 days to administer the same number of doses. It took the longest [...]

A total of 4 billion doses of COVID-19 vaccines have been used worldwide2021-11-19T14:09:43+03:00

New data on the safety of octreotide

2021-11-19T14:05:25+03:00

2 August 2021 EMA/PRAC/380226/2021 Corr2 Pharmacovigilance Risk Assessment Committee (PRAC) PRACTICAL recommendations on signals Adopted at the July 5-8, 2021 PRAC meeting This document provides an overview of the recommendations adopted by the Office of Pharmacovigilance PRAC (Review and Assessment Committee) signals discussed at the July 5-8, 2021 meeting You can find this document here [...]

New data on the safety of octreotide2021-11-19T14:05:25+03:00

Change of the Instructions for Medical Use for Octreotide

2021-11-19T14:00:47+03:00

It is worth paying attention to the following information: "4.4. Special warnings and precautions for use Function of the pancreas: Exocrine pancreatic insufficiency was observed in some patients treated with octreotide due to gastroenteropancreatic neuroendocrine tumors. Symptoms may include steatorrhea, liquid stools, bloating, and weight loss. In symptomatic patients, screening and appropriate treatment according to [...]

Change of the Instructions for Medical Use for Octreotide2021-11-19T14:00:47+03:00

Outstaffing an qualified person for pharmacovigilance

2021-11-19T13:56:38+03:00

Our company offers such services as outstaffing of qualified persons for pharmacovigilance (QPPV/LCCPV) The main purpose of outstaffing service is to solve the issues associated with the optimization of staffing and with the operation of the company's budget, as well as reducing the risks associated with the resolution of labor disputes. All companies need good [...]

Outstaffing an qualified person for pharmacovigilance2021-11-19T13:56:38+03:00

Hydrochlorothiazide/Spironolactone: CMDh Scientific Findings and Basis for Changes, Amendments to Product Information and Implementation Schedule – PSUSA / 00001662/202101

2021-11-19T13:48:11+03:00

Given the available data from the literature on acute respiratory toxicity, including acute respiratory distress syndrome, as well as spontaneous reports with some cases of close temporal relationship, positive recall, and given a plausible mechanism of action, PRAC reviews the causal relationship between hydrochlorothiazide/spironolactone and acute respiratory distress syndrome, and medical professionals should be warned [...]

Hydrochlorothiazide/Spironolactone: CMDh Scientific Findings and Basis for Changes, Amendments to Product Information and Implementation Schedule – PSUSA / 00001662/2021012021-11-19T13:48:11+03:00
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