To authorization applicants and manufacturers of medicinal products containing dipyridamole as an active ingredient
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), [...]
On new data on the safety of the drug Ixel (INN — Milnacipran)
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 [...]
Information letter dated 07.10.2021 No. 01I-1295/21 About changing email addresses
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 [...]
Safety variations for Ponatinib
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 [...]
Boequivalence studies
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 [...]
National Pharmacovigilance Research Center took part in the XVII conference «Actual problems of ensuring the quality of drug and medical care»
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 [...]
National Pharmacovigilance Research Center at the Eurasian Pharmaceutical Summit 2021
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 [...]
Medicinal product authorization
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 [...]