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On amendments to the general characteristics (SPC) and instructions for medical use (PIL) of medicinal products containing indapamide as an active ingredient

Елена Матвеева2021-10-28T14:12:22+03:00

Information on erectile dysfunction, hypomagnesemia, hypochloremia, hypokalemia, hyponatremia should be included in the instructions (short medicinal product characteristics, PIL) of products containing indapamide. data source and details

On amendments to the general characteristics (SPC) and instructions for medical use (PIL) of medicinal products containing indapamide as an active ingredientЕлена Матвеева2021-10-28T14:12:22+03:00

To authorization applicants and manufacturers of medicinal products containing dipyridamole as an active ingredient

Елена Матвеева2021-10-28T13:51:20+03:00

In connection with the letter of the Federal State Budgetary Institution "Scientific Center for the Expertise of Medicinal Products" of the Ministry of Health of Russia dated 09.09.2021 No. 22592 (input No. 2-180129 dated 09.10.2021), the Department of State Regulation of Medicines Circulation informs Of the Russian Federation of medicinal products for medical use containing [...]

To authorization applicants and manufacturers of medicinal products containing dipyridamole as an active ingredientЕлена Матвеева2021-10-28T13:51:20+03:00

On new data on the safety of the drug Ixel (INN — Milnacipran)

Елена Матвеева2021-10-27T13:43:39+03:00

Added information on the possibility of developing serotonin syndrome when combined with Buprenorphine (based on the PRAC recommendation). 4.4. Special warnings and precautions for use Interaction with other drugs and other forms of interaction Information has been added on the possibility of postpartum hemorrhage during therapy with selective serotonin reuptake inhibitors (SSRIs) and serotonin and [...]

On new data on the safety of the drug Ixel (INN — Milnacipran)Елена Матвеева2021-10-27T13:43:39+03:00

Information letter dated 07.10.2021 No. 01I-1295/21 About changing email addresses

Елена Матвеева2021-10-25T16:50:33+03:00

The Federal Service for Surveillance in Healthcare, as part of the execution of the state function of organizing and conducting pharmacovigilance, informs about the termination of the functioning of the e-mail domain @roszdravnadzor.ru. Currently, the @roszdravnadzor.gov.ru domain is operating, including email addresses for collecting information on pharmacovigilance such as pharm@ roszdravnadzor.gov.ru (for MA holders and [...]

Information letter dated 07.10.2021 No. 01I-1295/21 About changing email addressesЕлена Матвеева2021-10-25T16:50:33+03:00

Safety variations for Ponatinib

Елена Матвеева2021-10-25T16:42:33+03:00

After reviewing the available evidence and evaluating the evidence provided by the relevant Marketing Authorization Holder (MAH), PRAC agreed that the product information for Ponatinib should be updated to reflect the risk of panniculitis. data source and details

Safety variations for PonatinibЕлена Матвеева2021-10-25T16:42:33+03:00

Boequivalence studies

Елена Матвеева2021-10-25T15:07:37+03:00

Bioequivalence (pharmacokinetic equivalence) is the degree of similarity of a pharmaceutically equivalent drug to a reference drug (usually a generic drug to an original proprietary drug). Determined experimentally, in vivo. As you know, after the development and registration (authorization) of a medicinal product, the product enters the pharmaceutical market. The developer is the owner of [...]

Boequivalence studiesЕлена Матвеева2021-10-25T15:07:37+03:00

National Pharmacovigilance Research Center took part in the XVII conference «Actual problems of ensuring the quality of drug and medical care»

Елена Матвеева2021-10-31T23:07:57+03:00

On October 17-19, 2021, the XVII annual interregional conference "Actual problems of ensuring the quality of drug and medical care" was held online On October 19, Krasheninnikov A. - Doctor of Pharmaceutical Sciences, General Director of the National Scientific Center for Pharmacovigilance, presented a report "Normative regulation of monitoring the effectiveness and safety of [...]

National Pharmacovigilance Research Center took part in the XVII conference «Actual problems of ensuring the quality of drug and medical care»Елена Матвеева2021-10-31T23:07:57+03:00

National Pharmacovigilance Research Center at the Eurasian Pharmaceutical Summit 2021
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National Pharmacovigilance Research Center at the Eurasian Pharmaceutical Summit 2021

Елена Матвеева2021-11-07T21:26:25+03:00

The Eurasian Pharmaceutical Summit was held on September 12-13, 2021. Our General Director, A.E. Krasheninnikov, took part in it. Anatoly Evgenievich was the moderator of a separate session on the following topic "Mandatory registration of medicines under the rules of the EAEU in action. Prospects for the introduction of a system of accelerated drug registration [...]

National Pharmacovigilance Research Center at the Eurasian Pharmaceutical Summit 2021Елена Матвеева2021-11-07T21:26:25+03:00

Medicinal product authorization

Елена Матвеева2021-10-25T15:30:10+03:00

In order for a drug to enter the Russian market, it is required to go through several stages, the very first of which is an affirmative registration, or revision examination. The process involves checking your product by the state for safety, efficacy in relation to the indicated pharmacological properties. The end result is the issuance [...]

Medicinal product authorizationЕлена Матвеева2021-10-25T15:30:10+03:00