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.
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Company Name Title of Study Update Date
AstraZeneca Taiwan Limited Prevalence of Atherosclerotic Disease in Asian subjects not on lipid-lowering agents, but with at least two CVD risk factors 2011-12-16
Johnson & Johnson Taiwan Ltd. Early Access to TMC114 in Combination with Low-dose ritonavir (TMC114/r) and Other Antiretrovirals (ARVs) for Treatment-naïve or TMC114-naïve, Early Treatment-experienced in HIV-1 Infected Patients. 2011-11-23
Novartis (Taiwan) Co., Ltd. An observational, multinational, multi-center, prospective, open-label study to assess effectiveness, safety and tolerability in patients with arterial hypertension receiving amlodipine/valsartan in a real-world setting 2011-10-13
Pfizer Ltd. A PHASE 4, MULTI NATIONAL, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF VARENICLINE COMPARED TO PLACEBO FOR SMOKING CESSATION THROUGH REDUCTION 2011-09-21
Novartis (Taiwan) Co., Ltd. An observational, prospective, open-label study to assess effectiveness, safety and tolerability of once-yearly treatment with zoledronic acid in osteoporotic patients in a real-world setting (AZURE study). 2011-08-31
Novartis (Taiwan) Co., Ltd. A 52-week, prospective, multi-center, open-label study to assess the tolerability of rivastigmine before and after switching from oral formulation to transdermal patch in patients with Alzheimer’s dementia in a controlled titration schedule. 2011-08-31
Merck Ltd. Taiwan A post marketing surveillance study of cetuximab in patients with squamous cell carcinoma of head and neck (SCCHN) 2011-06-30
Merck Ltd. Taiwan Impact of Nursing Care Management Program on Erbitux® (Cetuximab) in Metastatic Colorectal Cancer 2011-06-23
Novartis (Taiwan) Co., Ltd. A prospective, open-label study to assess caregivers preference and treatment outcome in patients with mild to moderate Alzheimer’s Disease treated with oral or transdermal therapy in Taiwan (RECAP study) 2011-06-01
Novartis (Taiwan) Co., Ltd. A prospective, open-label study to assess caregivers preference and treatment outcome in patients with mild to moderate Alzheimer’s Disease treated with oral or transdermal therapy in Taiwan (RECAP study) 2011-06-01
Novartis (Taiwan) Co., Ltd. A 52-week, multicenter, prospective, observational, non-interventional, open-label study to asses the effectiveness, safety and tolerability of Certican in kidney transplant patients 2011-06-01
Novartis (Taiwan) Co., Ltd. A prospective, open-label, observational, non-interventional, multicenter, 52-week study on treatment effectiveness, safety and persistence with add-on omalizumab (Xolair®) in specific patient population with uncontrolled severe persistent asthma (EXACT) 2011-05-26
Novartis (Taiwan) Co., Ltd. OBSERVATIONAL STUDY TO COLLECT INFORMATION ON SAFETY AND EFFECTIVENESS OF A SINGLE-PILL COMBINATION OF 5MG AMLODIPINE AND 80MG VALSARTAN IN THE TREATMENT OF HYPERTENSION 2011-05-19
Novartis (Taiwan) Co., Ltd. An observational, multi-center, prospective, open-label study to assess effectiveness, safety and tolerability in diabetic patients with arterial hypertension and albuminuria receiving aliskiren in a real-world setting
2011-05-19
Pfizer Ltd. Tigecycline in-vitro Surveillance Study in Taiwan 2011-04-20
Pfizer Ltd. A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-Weekly Administration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and Methotrexate 2011-04-20
Bayer Taiwan Co. Ltd. Prospective, observational study on advanced RCC patient with Nexavar® treatment in Taiwan 2010-12-15
Janssen-Cilag Taiwan Velcade Observational Study 2010-12-06
AstraZeneca Taiwan Limited SAVOR: Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus. A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients with Type 2 Diabetes. 2010-11-10
Bayer Taiwan Co. Ltd. GARDIAN, Gadovist® in Routine Diagnostic MRI Administration in Non-selected patients 2010-09-06
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