Results 11 to 20 of about 51,036 (300)

Analysis of Suffix Use for Biosimilar Product Identification in Postmarketing Adverse Event Reporting. [PDF]

Clin Pharmacol Ther
Accurate identification of medicines used in adverse event reports is crucial for effective postmarketing safety surveillance. The US Food and Drug Administration's (FDA) four‐letter suffix naming convention was designed to facilitate accurate biological product identification, but the extent to which these suffixes have been incorporated into ...
Stojanovic D, Wolf L, Ricci MS, Muñoz MA.   +3 more
europepmc   +2 more sources

Sex-disaggregated outcomes of adverse events after COVID-19 vaccination: A Dutch cohort study and review of the literature

Frontiers in Immunology, 2023
BackgroundAlbeit the need for sex-disaggregated results of adverse events after immunization (AEFIs) is gaining attention since the COVID-19 pandemic, studies with emphasis on sexual dimorphism in response to COVID-19 vaccination are relatively scarce ...
Janneke W. Duijster, Thomas Lieber, Silvia Pacelli, Silvia Pacelli, Leontine Van Balveren, Loes S. Ruijs, Monika Raethke, Agnes Kant, Florence Van Hunsel   +8 more
doaj   +1 more source

Pharmacovigilance

International journal of health sciences, 2022
The World Health Organization (WHO) defines Pharmacovigilance as the science & activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug related problem. The National Pharmacovigilance Programme (NPVP) was launched in 2004 with World Bank funding till 2009, which was renamed as Pharmacovigilance
Shruti Brahmbhatt, Mahavirsingh Rajput
openaire   +1 more source

Organisation of the Russian Pharmacovigilance System: Survey of Pharmacovigilance Officers

Безопасность и риск фармакотерапии, 2021
Ensuring the safety of pharmacotherapy is a priority of the national regulatory health policy and is enshrined in the international and federal legislation.
A. E. Krasheninnikov, A. V. Matveev, S. D. Marchenko   +2 more
doaj   +1 more source

Model estimates of hospitalization discharge rates for norovirus gastroenteritis in Europe, 2004–2015

BMC Infectious Diseases, 2021
Background Norovirus is an important cause of acute gastroenteritis globally. However, norovirus is rarely laboratory confirmed or recorded explicitly as a cause of hospitalization.
Elsa Negro-Calduch, Tom Cattaert, Thomas Verstraeten   +2 more
doaj   +1 more source

Knowledge, attitude and practice of pharmacovigilance among Nepalese health professionals

, 2022
Introduction: Although Nepal joined the WHO program for International Drug Monitoring in 2006, published data about Nepalese health professionals’ understanding of pharmacovigilance and spontaneous reporting of adverse drug reactions (ADRs) is limited ...
White, K., Shrestha, S.C., Ghebremeskel, K., Tewfik, S., Minelli, C., Thapa, P., Tewfik, I.   +6 more
core   +1 more source

The Case of Catalan Regional Activities that Propelled the Spanish Pharmacovigilance System

, 2023
The Spanish System of Pharmacovigilance (SSPV) started its activities almost 40 years ago, in 1985. Of particular interest to others considering various options for developing pharmacovigilance systems is ...
Figueras, Albert, Bieliaieva, Kseniya, Marquez, Patricio V., Wang, Huihui   +3 more
core   +1 more source

Identification of International Society on Thrombosis and Haemostasis major and clinically relevant non-major bleed events from electronic health records: a novel algorithm to enhance data utilisation from real-world sources

International Journal of Population Data Science, 2023
Introduction In randomised controlled trials (RCTs), bleeding outcomes are often assessed using definitions provided by the International Society on Thrombosis and Haemostasis (ISTH).
Alexander Hartenstein, Khaled Abdelgawwad, Frank Kleinjung, Stephen Privitera, Thomas Viethen, Tatsiana Vaitsiakhovich   +5 more
doaj   +1 more source

Suvorexant (Belsomra® Tablets 10, 15, and 20 mg): Japanese Drug-Use Results Survey

Drugs in R&D, 2018
Background We report on the results of a Japanese postmarketing drug-use survey of suvorexant (Belsomra®) tablets. Methods A survey with a ≤ 6-month observation period after the start of administration was conducted, targeting insomnia patients who were ...
Yuko Asai, Hideki Sano, Makoto Miyazaki, Mika Iwakura, Yoshikazu Maeda, Mitsuyoshi Hara   +5 more
doaj   +1 more source

Safety and Effectiveness of Molnupiravir (LAGEVRIO®) Capsules in Japanese Patients with COVID-19: Interim Report of Post-marketing Surveillance in Japan

Infectious Diseases and Therapy, 2023
Introduction Molnupiravir is an oral antiviral drug that received special approval for emergency use in Japan on December 24 2021 for infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Masahiro Kimata, Asuka Watanabe, Yukiko Yanagida, Daisuke Kinoshita, Shinichiroh Maekawa   +4 more
doaj   +1 more source