In order to understand if there is other unknown side effect during the clinical trail, the PMS (Post-Marketing Study) will be conducted to learn more treatment experiences on patients, and collect their information for further study.
No. 9 of IRPMA COP Benchmarks regulates that all PMS shall go through JIRB, IRB or Ethics Committee and must be registered on the website of IRPMA PMS registry system. It is to ensure the studies conducted on patients have been approved by JIRB, IRB and protect patient’s right of privacy. The public can also get the information and objective of the PMS through the registry system.
Title of Study
Post-Marketing Surveillance study to observe INLYTA® treatment dosing pattern, safety and effectiveness in Taiwan real world routine practice 2015-11-25
Novartis (Taiwan) Co., Ltd.
A 12-week treatment, multi-center, randomized, double-blind, double-dummy, parallel group study to assess the efficacy and safety of switching from salmeterol/fluticasone to QVA149 (indacaterol maleate/glycopyrronium bromide) in symptomatic COPD patients 2015-11-23
Novartis (Taiwan) Co., Ltd.
An observational, multi-center, prospective, open-label study to assess effectiveness, safety and tolerability of treatment with single pill combination of vildagliptin plus metformin(50mg/500mg, 50mg/850mg, 50mg/1000mg film-coated tablets)in type 2 diabetes mellitus patients in a real-world setting 2015-11-12
Chugai Pharma Taiwan Ltd.
Efficacy and safety evaluation of tocilizumab monotherapy in Taiwan population 2015-08-18
Boehringer Ingelheim Taiwan Limited
GLORIA-AF: Global Registry, on Long-Term Oral Anti-thrombotic TReatment In
PAtients with Atrial Fibrillation. (Phase II/III) 2015-06-24
A non-interventional, global, cross-sectional study to Check Atrial Fibrillation rates in patients 65 years or older by means of a device for opportunistic screening 2015-05-21
A Phase 3b/4 Randomized Double Blind Study Of 5 mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis 2015-04-29
Bayer Taiwan Co., Ltd.
Xarelto® for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE) in Latin America, EMEA and Asia 2015-04-29
An open-label, prospective interventional study of the tolerability and efficacy of oral Harnalidge® OCAS®(Tamsulosin) 0.4 mg in patients who are unsatisfied with the treatment of Tamsulosin 0.2 mg 2015-04-29
RACER (Ranibizumab AMD Clinical Efficacy in Real world practice): A multicenter, open-label, prospective, non-interventional study to evaluate the effectiveness and safety of Lucentis (ranibizumab) in naive wet Age-Related Macular Degeneration (wAMD) patients with vision impairment due to choroidal neovavscularization (CNV) over a 12-month observational period under real life conditions RACER (臨床評估年齡相關性黃斑部退化病變病患使用 ranibizumab 治療之有效性)：一項為期 12 個月，多中心、開放性、前瞻性、非介入性研究，觀察臨床使用樂舒晴(Lucentis®/ranibizumab)治療血管新生型(濕性)年齡相關性黃斑部退化病變 (wAMD)引起脈絡膜血管新生(CNV)而導致視覺障礙，且未曾接受過治療之病患，其有效性與安全性評估。 2015-04-29
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