Information letter No. 01I-1430/21 of 26.10.2021 on the introduction of new safety data in the instructions for use of the drug Nexium® (INN — Esomeprazole) 10 mg
The following sections of the instructions for medical use of the drug have been amended; - "Side Effects." - The information has been updated. Information was added to subsection: "Skin and subcutaneous tissue disorders": acute [...]
Carbamazepine — Scientific Findings and Basis for Modification of Registration Approval — PSUSA-00000539-202012
PRAC proposes the following changes to the Smpc: Interaction with brivaracetam Hyperammonemia Use during pregnancy and in women of childbearing age data source and details
Warfarin — anticoagulant-related nephropathy
PRAC analyzed pooled data from spontaneous case reports, clinical trials, and the literature regarding the risk of anticoagulant-associated nephropathy in patients receiving warfarin. PRAC has agreed that MAH of drugs containing warfarin should submit a [...]
Cefoperazone — Scientific Conclusions and Basis for Modification of Registration Approval Terms — PSUSA-00000597-202101 (Hematuria)
In view of the available data on coagulopathy and bleeding from clinical trials, literature, spontaneous reports, and given a plausible mechanism of action, PRAC believes a causal relationship between cefoperazone and hematuria to be at [...]
Бесплатный научно-практический вебинар по вопросам фармаконадзора
Уважаемые коллеги! Приглашаем Вас 26 ноября 2021 принять участие в бесплатном научно-практическом вебинаре по вопросам фармаконадзора, организатором которого является «Национальный научный центр Фармаконадзора». Начало вебинара в 10.00. В рамках вебинара будут рассмотрены актуальные вопросы: [...]
PRACTICAL ASPECTS OF PHARMACOVIGILANCE IN THE EAEU. IV Scientific and Practical online Conference
Dear colleagues! We invite you on December 15, 2021 to the annual scientific and practical online conference on pharmacovigilance, organized by the Pirogov Russian National Research Medical University, an autonomous non-profit organization "National Scientific [...]
ПРАКТИЧЕСКИЕ АСПЕКТЫ ФАРМАКОНАДЗОРА в ЕАЭС. IV научно-практическая онлайн-конференция
Уважаемые коллеги! Приглашаем Вас 15 декабря 2021 на ежегодную научно-практическую онлайн-конференцию по вопросам фармаконадзора, организаторами которой являются ФГАОУ ВО Российский национальный исследовательский медицинский университет имени Н. И. Пирогова, автономная некоммерческая организация «Национальный научный центр [...]
5-fluorouracil (intravenous) — Scientific findings and reasons for changing the conditions of the marketing authorization — PSUSA-00000007-202012
Taking into account the available data on risk (s) from the literature and spontaneous reports, including in some cases a close temporal relationship, positive challenge-response, and/or re-challenge, PRAC consider that - the relationship between 5-fluorouracil [...]