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References from Comparison of safety profiles for dapagliflozin based on EMA and FDA safety issues: Challenges and future of post-marketing surveillance in Korea. Local targets link to admitted publications; unresolved targets remain external evidence.
Risk Management Plans: are they a tool for improving drug safety?.
10.1007/s00228-010-0848-8 · 2010 · External reference
Post-authorisation safety studies (PASS)
External reference
Postmarket Requirements and Commitments.
2023 · External reference
Real-World Data in the Postapproval Setting as Applied by the EMA and the US FDA.
10.1016/j.clinthera.2021.12.010 · 2022 · External reference
Guideline on Re-Examination Affairs of New Drug,etc
2023 · External reference
Guideline on Risk Management Plan for Medicines (article in Korean).
2024 · External reference
Dapagliflozin: a review in type 2 diabetes
10.1007/s40265-019-01148-3 · 2019 · External reference
Catalogue of RWD studies
External reference
Channeling postmarketing patient data into pharmaceutical regulatory systems.
10.1016/j.drudis.2014.07.011 · 2014 · External reference
Pharmaceutical Affairs Act Article 32 (Re-Examination of New Drugs, etc.). [about 1 screens].
External reference
Drug Detailed Information: Forxiga (Dapagliflozin) (article in Korean). [about 1 screens].
External reference
Communicating emerging risks of SGLT2 inhibitors-timeliness and transparency of medicine regulators
10.1136/bmj.m1107 · 2020 · External reference
Postmarket Safety Communication for Protection of Public Health: A Comparison of Regulatory Policy in Australia, Canada, the European Union, and the United States
10.1002/cpt.2010 · 2021 · External reference
Evaluation of FDA safety-related drug label changes in 2010.
10.1002/pds.3395 · 2013 · External reference
GUIDANCE DOCUMENT: Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products—Content and Format
2011 · External reference
Forxiga: dapagliflozin. [about 1 screens]
External reference
Drugs@FDA: FDA-Approved Drugs. [about 1 screens]
External reference
Introduction of KAERS. [about 1 screens].
External reference
Data Mining at FDA—White Paper
2018 · External reference
Guideline on the use of statistical signal detection methods in the EudraVigilance data analysis system (EMEA/106464/2006 rev.1)
2006 · External reference
Unresolved reference
External reference
SGLT2 inhibitors associated pancreatitis: signal identification through disproportionality analysis of spontaneous reports and review of case reports.
10.1007/s11096-022-01476-7 · 2022 · External reference
A Bayesian neural network method for adverse drug reaction signal generation
10.1007/s002280050466 · 1998 · External reference
A data mining approach for signal detection and analysis.
10.2165/00002018-200225060-00002 · 2002 · External reference
The reporting odds ratio and its advantages over the proportional reporting ratio.
10.1002/pds.1001 · 2004 · External reference
Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports.
10.1002/pds.677 · 2001 · External reference
VigiBase, the WHO global ICSR database system: basic facts.
10.1177/009286150804200501 · 2008 · External reference
Use of Sodium-Glucose Cotransporter 2 Inhibitors in Patients With Type 1 Diabetes and Rates of Diabetic Ketoacidosis
10.2337/dc19-1481 · 2019 · External reference
Application number: 202293Orig1s000. medical review(s). [about 494 screens].
External reference
EUPAS12116: Comparison of the Risk of Cancer Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments
2016 · External reference
PRAC assessment report
2017 · External reference
Forxiga: dapagliflozin
2012 · External reference
CENTER FOR DRUG EVALUATION AND RESEARCH. [about 494 screens].
External reference
HIGHLIGHTS OF PRESCRIBING INFORMATION
2014 · External reference
Assessment report
2019 · External reference
Effects of dapagliflozin on cardiovascular risk factors.
10.3810/pgm.2013.05.2667 · 2013 · External reference
Dapagliflozin decreases small dense low-density lipoprotein-cholesterol and increases high-density lipoprotein 2-cholesterol in patients with type 2 diabetes: comparison with sitagliptin
2017 · External reference
Post-authorization safety studies of acute liver injury and severe complications of urinary tract infection in patients with type 2 diabetes exposed to dapagliflozin in a real-world setting.
10.1007/s40264-022-01262-4 · 2023 · External reference
Comparison of the Risk of Acute Liver Injury Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments
2024 · External reference
European Medicines Agency investigates findings on pancreatic risks with GLP-1-based therapies for type-2 diabetes.
2013 · External reference
Glucuretic effects and renal safety of dapagliflozin in patients with type 2 diabetes
10.1177/2042018815575273 · 2015 · External reference
Extension of indication variation assessment report.
2012 · External reference
Post-authorization safety study of hospitalization for acute kidney injury in patients with type 2 diabetes exposed to Dapagliflozin in a real-world setting
10.1007/s40264-022-01263-3 · 2023 · External reference
HIGHLIGHTS OF PRESCRIBING INFORMATION
2020 · External reference
CENTER FOR DRUG EVALUATION AND RESEARCH
2020 · External reference
Real-world evidence for regulatory decision-making: guidance from around the world.
10.1016/j.clinthera.2022.01.012 · 2022 · External reference
Post-marketing drug safety management to be unified under ’Risk Management Plan’ (article in Korean).
2020 · External reference
Medical information database studies guideline (article in Korean)
2021 · External reference
