Safety of Brexanolone in Adults with Postpartum Depression: Postmarketing Surveillance Data [PDF]
Drugs - Real World Outcomes, 2023 Background Brexanolone is currently the only medication approved by the US FDA for the treatment of postpartum depression (PPD) in patients ≥15 years. Brexanolone is available commercially only through a restricted program (ZULRESSO® Risk Evaluation and ...
Svetlana Garafola +2 more
doaj +4 more sources
Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance [PDF]
Frontiers in Pharmacology, 2022 Background: Postmarketing safety analysis is an effective supplement for new drugs in clinical practice. Therefore, we aimed to systematically assess the safety of oral nemonoxacin malate, the first approved C-8-methoxy non-fluorinated quinolone, in ...
Jinyi Yuan +5 more
doaj +2 more sources
Safety and Effectiveness of OnabotulinumtoxinA in Patients with Laryngeal Dystonia: Final Report of a 52-Week, Multicenter Postmarketing Surveillance Study [PDF]
Toxins, 2023 This postmarketing surveillance study was conducted to evaluate the safety and effectiveness of onabotulinumtoxinA in Japanese patients with laryngeal dystonia (LD).
Shigeomi Iimura +6 more
doaj +2 more sources
Safety and effectiveness of apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A regulatory postmarketing surveillance, the STANDARD study [PDF]
Journal of Arrhythmia, 2019 Background Apixaban, a non‐vitamin K oral anticoagulant (NOAC), was approved in Japan in 2012 for the prevention of thromboembolic events in patients with nonvalvular atrial fibrillation (NVAF).
Hiroshi Inoue +5 more
doaj +2 more sources
Idarucizumab for Emergency Reversal of the Anticoagulant Effects of Dabigatran: Final Results of a Japanese Postmarketing Surveillance Study [PDF]
Cardiology and Therapy, 2023 Introduction Idarucizumab, a monoclonal antibody fragment that rapidly reverses the anticoagulant effects of dabigatran, was approved in Japan in September 2016, at which time an all-case, postmarketing surveillance (PMS) study was initiated to collect ...
Masahiro Yasaka +7 more
doaj +2 more sources
Real‐World Outcomes of Avelumab Maintenance Therapy in Patients With Curatively Unresectable Urothelial Carcinoma in Japan: Results From the Final Analysis of Postmarketing Surveillance [PDF]
Cancer MedicineBackground Avelumab maintenance therapy was approved in Japan in February 2021 for the treatment of curatively unresectable urothelial carcinoma (UC) that has not progressed after prior chemotherapy based on results from the JAVELIN Bladder 100 phase 3 ...
Eiji Kikuchi +7 more
doaj +2 more sources
Real-World Outcomes of Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration: A Large-Scale Postmarketing Surveillance in Korea [PDF]
Clinical Ophthalmology, 2021 Gahyung Ryu,1,2 Donghyoun Noh,1,2 Guihyun Moon,3 Min Sagong1,2 1Department of Ophthalmology, Yeungnam University College of Medicine, Daegu, Republic of Korea; 2Yeungnam Eye Center, Yeungnam University Hospital, Daegu, Republic of Korea; 3Bayer Korea Ltd,
Ryu G, Noh D, Moon G, Sagong M
doaj +2 more sources
A multicenter, postmarketing surveillance of elobixibat in patients with chronic constipation in Japan: A final analysis report [PDF]
SAGE Open MedicineObjective: An interim analysis of postmarketing surveillance reported the safety and efficacy of elobixibat, a laxative medication that inhibits the ileal bile acid transporter, at 4 weeks in approximately 1000 patients with chronic constipation in Japan.
Atsushi Nakajima +4 more
doaj +2 more sources
Topical Sirolimus 0.2% Gel for the Management of Tuberous Sclerosis Complex-Related Cutaneous Manifestations: An Interim Analysis of Postmarketing Surveillance in Japan. [PDF]
Dermatol Ther (Heidelb), 2023 Egami A +4 more
europepmc +3 more sources