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https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/selected-pharmacometric-reviews-guidances-and-presentations
Natpara Edoxaban Eliglustat Suvorexant Simeprevir Guidances End-of-Phase 2A Meetings
https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/april-june-2016-potential-signals-serious-risksnew-safety-information-identified-fda-adverse-event
...and sofosbuvir) tablets Olysio (simeprevir) capsules Sovaldi (sofosbuvir) tablets
https://www.fda.gov/media/142206/download
...language pertaining to withdrawn drug simeprevir was removed from section 7 of Prezcobix
https://www.fda.gov/media/142255/download
...language pertaining to withdrawn drug simeprevir was removed from section 7 of Prezcobix
https://www.fda.gov/media/131200/download
...(MCL) NDA 205123 ORIG - 1 OLYSIO SIMEPREVIR JANSSEN PRODUCTS LP 22-Nov-2013 Treatment
https://www.fda.gov/media/164706/download
...of Drug Interactions after Adding Simeprevir- or Sofosbuvir- containing therapy...drug-drug interactions upon addition of simeprevir- or sofosbuvir- ...
https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling
Warnings, Clinical Pharmacology Simeprevir Infectious Diseases IFNL3 (IL28B)
https://www.fda.gov/media/159488/download
...(HCV) NS3/4A protease inhibitor SIMEPREVIR hepatitis C virus (HCV) NS3/4A protease...protease inhibitor SIMEPREVIR hepatitis C virus (HCV) NS3/4A ...
https://www.fda.gov/media/159446/download
...(HCV) NS3/4A protease inhibitor SIMEPREVIR hepatitis C virus (HCV) NS3/4A protease...protease inhibitor SIMEPREVIR hepatitis C virus (HCV) NS3/4A ...
https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/october-december-2015-potential-signals-serious-risksnew-safety-information-identified-fda-adverse
...(ledipasvir/sofosbuvir) tablet Olysio (simeprevir) capsule Sovaldi (sofosbuvir) tablet
https://www.fda.gov/media/177252/download
...(HCV) NS3/4A protease inhibitor SIMEPREVIR hepatitis C virus (HCV) NS3/4A protease
https://www.fda.gov/media/174295/download
...(HCV) NS3/4A protease inhibitor SIMEPREVIR hepatitis C virus (HCV) NS3/4A protease
https://www.fda.gov/media/161333/download
...infection NDA 205123 ORIG - 1 OLYSIO SIMEPREVIR JANSSEN PRODUCTS LP 11/22/2013 Treatment
https://www.fda.gov/media/134175/download
...inducer on ibrutinib PK Yes 205123 Simeprevir OLYSIO 11/22/2013 • Assessing the...of a transporter (OATP1B1/3) on simeprevir disposition • Change of ...
https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/january-march-2015-potential-signals-serious-risksnew-safety-information-identified-fda-adverse
...(ledipasvir/sofosbuvir) tablet Olysio (simeprevir) capsule Sovaldi (sofosbuvir) tablet
https://www.fda.gov/media/134177/download
Drugs PBPK assessment OATP1B1/3 simeprevir, letermovir Exploratory Transporter
https://www.fda.gov/media/91861/download
...investigational drug daclatasvir or Olysio (simeprevir), with amiodarone. Patients should...direct acting antiviral, or Olysio (simeprevir) ...
https://www.fda.gov/media/93364/download
...and etravirine, rilpivirine, and simeprevir. This section of the submission and...Clinical Pharmacology Reviewer. Simeprevir (OLYSIO): 45 Reference ...
https://www.fda.gov/media/156478/download
...(HCV) NS3/4A protease inhibitor SIMEPREVIR hepatitis C virus (HCV) NS3/4A protease
https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-serious-slowing-heart-rate-when-antiarrhythmic-drug
...investigational drug daclatasvir or Olysio (simeprevir), with amiodarone. Patients should...direct acting antiviral, or Olysio (simeprevir) ...
