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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. |
| Company Name |
Title of Study |
Update Date |
| Novartis (Taiwan) Co., Ltd. |
A 48-week, prospective, non-interventional, observational post-marketing surveillance study to evaluate the cognitive, behavior and ability of function in patients with Alzheimer’s disease who receive a new prescription for rivastigmine |
2010-07-01 |
| Novartis (Taiwan) Co., Ltd. |
A prospective, open label, observational, non-interventional, multicenter study to assess the effectiveness and safety of Myfortic® (enteric-coated mycophenolate sodium) in de novo and maintenance kidney transplant recipients. |
2010-06-15 |
| Novartis (Taiwan) Co., Ltd. |
The Observational Registry Collecting Data On Gastroenteropancreatic Neuroendocrine Tumor Patients(GEP-NET Registry) |
2010-04-07 |
| Novartis (Taiwan) Co., Ltd. |
Single-arm, Observational, Safety Evaluation of Exjade in Patients with Transfusion Hemosiderosis |
2010-04-07 |
| Novartis (Taiwan) Co., Ltd. |
Quality of Life Evaluation of Prostate Cancer Patients with Bone Metastasis after Administration of Zometa (zoledronic acid) |
2010-04-07 |
| Novartis (Taiwan) Co., Ltd. |
Quality of Life Evaluation of Breast Cancer Patients with Bone Metastasis after Administration of Zometa (zoledronic acid) |
2010-04-07 |
| Novartis (Taiwan) Co., Ltd. |
EASTERN: Evaluation of Aliskiren: Safety, Tolerability, and Effectiveness in a Real-world settiNg (an observational, multi-center, prospective, open-label study to asses effectiveness, safety and tolerability in patients with hypertension receiving Rasilez® (aliskiren) in a real-world setting |
2010-04-07 |
| Novartis (Taiwan) Co., Ltd. |
An observational, multicenter study of Femara® in
ER+ and/ or PgR+ breast cancer patients under
conditions of general clinical practice
|
2010-04-07 |
| Novartis (Taiwan) Co., Ltd. |
A prospective, open-label, nonrandomized, multi-center, surveillance registry study to evaluate the safety, tolerability and effectiveness of telbivudine in treatment of chronic hepatitis B patients in Taiwan. |
2010-04-07 |
| Novartis (Taiwan) Co., Ltd. |
A prospective, non-interventional multicenter multinational registry of anemia patients requiring chronic transfusional therapy who are at risk for transfusional hemosiderosis |
2010-04-07 |
| Novartis (Taiwan) Co., Ltd. |
A prospective study to evaluate the safety and efficacy of Aclasta® (Zoledronic acid) in the treatment of osteoporosis in postmenopausal women |
2010-04-07 |
| Novartis (Taiwan) Co., Ltd. |
A non-interventional, multi-center, surveillance study to observe long-term safety of Exjade® in patients with myelodysplastic syndrome (MDS), aplastic anemia (AA) and other rare anemia patients at risk for chronic transfusional related iron overload |
2010-04-07 |
| Novartis (Taiwan) Co., Ltd. |
A multi-center single arm phase II study of adjuvant imatinib (glivec) in patients following the resection ofprimary gastrointestinal stromal tumor ( GIST) |
2010-04-07 |
| Novartis (Taiwan) Co., Ltd. |
A Multicentre, Open-label, Prospective, Non-interventional Study to the Evaluate Safety and Effectiveness, of Multiple Dose Intravitreal Injections (IVI) of Lucentis® (Ranibizumab) in Patients with Exudative Neovascular (wet) Age-Related Macular Degeneration (AMD) over a 12-Month Observational Period under Real Life Conditions (REAL) |
2010-04-07 |
| AstraZeneca Taiwan Limited |
A phase III, 12-week, double-blind, randomised, parallel-group, active-controlled, multinational, efficacy and safety study of Symbicort® Turbuhaler® 160/4.5 μg 2 inhalations bid compared to Oxis® Turbuhaler 4.5 μg 2 inhalations bid in patients with chronic obstructive pulmonary disease (COPD). |
2010-04-07 |
| Merck, Ltd. |
A prospective, multicentre, observational study on the predictive factors of ovarian response in ovulation induction (OI) with intrauterine insemination (IUI) of a Gonal-f NGP low-dose step-up regimen |
2010-01-26 |
| Novartis (Taiwan) Co., Ltd. |
Observational study of imatinib and blood level in CML patients after administration of imatinib mesylate |
2010-01-25 |
| Novartis (Taiwan) Co., Ltd. |
An Observational Study of Imatinib Dose Escalation in GIST Patients with Progressive Disease |
2010-01-25 |
| Janssen-Cilag Taiwan |
TEAMS: Topiramate in the treatment of Epilepsy: 1st Add-on vs. Mono-therapy study in neuro-Surgical patients. |
2010-01-11 |
| AstraZeneca Taiwan |
Real life Effectiveness of Symbicort® Maintenance and Reliever Therapy® (SMART) in Asthma Patients across Asia: SMARTASIA |
2009-10-26 |
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