Study of Safety of Medicinal Products in Pregnant Women in Crimea

2022-01-08T21:32:42+03:00

A. V. Matveev, E. A. Egorova, A. E. Krasheninnikov, E. I. Konyaeva https://doi.org/10.30895/2312-7821-2021-9-2-95-102 ABSTRACT According to international epidemiological studies, about 80% of women have to use medicinal products during pregnancy, mainly during the first weeks of organogenesis in the case of an unplanned pregnancy, and for the treatment of chronic diseases or acute conditions [...]

Study of Safety of Medicinal Products in Pregnant Women in Crimea2022-01-08T21:32:42+03:00

Organisation of the Russian Pharmacovigilance System: Survey of Pharmacovigilance

2022-01-08T17:35:16+03:00

A. E. Krasheninnikov, A. V. Matveev, S. D. Marchenko https://doi.org/10.30895/2312-7821-2021-9-3-154-160 ABSTRACT Ensuring the safety of pharmacotherapy is a priority of the national regulatory health policy and is enshrined in the international and federal legislation. Survey of qualified pharmacovigilance experts on current problems in pharmacovigilance is one of the tools for improving the pharmacovigilance system [...]

Organisation of the Russian Pharmacovigilance System: Survey of Pharmacovigilance2022-01-08T17:35:16+03:00

Results: PRACTICAL ASPECTS OF PHARMACOVIGILANCE IN THE EAEU

2021-12-27T02:28:43+03:00

On December 15, 2021, the annual scientific and practical online conference on pharmacovigilance was held, organized by the N. I. Pirogov Russian National Research Medical University, an autonomous non-profit organization "National Scientific Center for Pharmacovigilance", with the support of the company "Aforum". The conference was attended by experts from the Ministry of Health of [...]

Results: PRACTICAL ASPECTS OF PHARMACOVIGILANCE IN THE EAEU2021-12-27T02:28:43+03:00

Examination of readiness for inspection

2021-12-12T19:46:47+03:00

Inspection is a method of regulatory control by an authorized organization (usually regulatory) of the pharmacovigilance system of the inspected organization - the holder of registration certificates, the developer of medicines or another organization involved in the fulfillment of all or individual obligations under pharmacovigilance. Our company provides such a service as examination of [...]

Examination of readiness for inspection2021-12-12T19:46:47+03:00

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
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