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141. Sucroferric oxyhydroxide - Benefit assessment according to §35a Social Code Book V (dossier assessment)

October 2014]. URL: http://www.fachinfo.de. 4. European Medicines Agency. Velphoro: European public assessment report; product information [German] [online]. 13 October 2014 [accessed: 6 November 2014]. URL: http://www.ema.europa.eu/docs/de_DE/document_library/EPAR_- _Product_Information/human/002705/WC500175254.pdf. 5. Genzyme. Renvela 800 mg Filmtabletten: Fachinformation [online]. March 2014 [accessed: 13 November 2014]. URL: http://www.fachinfo.de. 6. Vifor Fresenius Medical Care Renal Pharma (...) Sucroferric oxyhydroxide - Benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Sucroferric Oxyhydroxid – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 22 December 2014). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A14-37

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

142. Dolutegravir/abacavir/lamivudine - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Dolutegravir/abacavir/lamivudine - Benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Dolutegravir/Abacavir/Lamivudin – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 18 December 2014). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports (...) – Commission No. A14-34 Dolutegravir/abacavir/ lamivudine – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-34 Version 1.0 Dolutegravir/abacavir/lamivudine – Benefit assessment acc. to §35a SGB V 18 Dec 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dolutegravir/abacavir/lamivudine – Benefit assessment according to §35a SGB V Commissioning agency

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

143. Lurasidone - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A14-42 Version 1.0 Lurasidone – Benefit assessment acc. to §35a Social Code Book V 28 January 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Rüdiger Mielke, Chair of Neuroscience (...) daily dose; effect estimate: mean difference .. 16 Extract of dossier assessment A14-42 Version 1.0 Lurasidone – Benefit assessment acc. to §35a Social Code Book V 28 January 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - vi - List of abbreviations Abbreviation Meaning ACT appropriate comparator therapy AE adverse event BAS Barnes Akathisia Scale CGI-S Clinical Global Impression Scale of Severity CI confidence interval EMA European Medicines Agency G-BA Gemeinsamer

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

144. Sipuleucel-T - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Commission No.: A14-38 Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A14-38 Version 1.0 Sipuleucel-T – Benefit assessment acc. to §35a Social Code Book V 23 December 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Gerhard Jakse, Rhine (...) of sipuleucel-T, particularly regarding the different subsequent therapies on disease progression and the lack of differences in progression-free survival between the study arms. This led to a deviating vote from some of the members of the Committee for Medicinal Products for Human Use (CHMP). Extract of dossier assessment A14-38 Version 1.0 Sipuleucel-T – Benefit assessment acc. to §35a Social Code Book V 23 December 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - 3 - Mortality Overall

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

145. Idelalisib - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Idelalisib - Benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Assessment module I, Sections I 2.1 to I 2.9, and Assessment module II, Sections II 2.1 to II 2.6, of the dossier assessment Idelalisib – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 22 December 2014). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative (...) and legally binding. IQWiG Reports – Commission No. A14-35 Idelalisib – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-35 Version 1.0 Idelalisib – Benefit assessment acc. to §35a Social Code Book V 22 December 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Idelalisib – Benefit assessment according to §35a Social Code Book V Commissioning agency

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

146. Simoctocog alfa - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Internal Commission No.: A14-41 Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A14-41 Version 1.0 Simoctocog alfa – Benefit assessment acc. to §35a Social Code Book V 11 February 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Bernd Pötzsch (...) – extent and probability of added benefit 6 3 Table numbers start with “2” as numbering follows that of the full dossier assessment. Extract of dossier assessment A14-41 Version 1.0 Simoctocog alfa – Benefit assessment acc. to §35a Social Code Book V 11 February 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - v - List of abbreviations Abbreviation Meaning ACT appropriate comparator therapy EMA European Medicines Agency G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) IQWiG

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

147. Umeclidinium/vilanterol - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Umeclidinium/vilanterol - Benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Umeclidinium/Vilanterol – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 October 2014). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A14-22 (...) Umeclidinium/vilanterol – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-22 Version 1.0 Umeclidinium/vilanterol – Benefit assessment acc. to §35a SGB V 13 Oct 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Umeclidinium/vilanterol – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

148. Eribulin (new therapeutic indication) - Benefit assessment according to § 35a Social Code Book V (dossier assessment)

Internal Commission No.: A14-25 Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A14-25 Version 1.0 Eribulin – Benefit assessment acc. to §35a Social Code Book V 31 October 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Rolf Kreienberg, Women’s (...) Eribulin (new therapeutic indication) - Benefit assessment according to § 35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Eribulin – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 31 October 2014). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A14-25

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

149. Vedolizumab - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Vedolizumab - Benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Assessment module I, Sections I 2.1 to I 2.6, and Assessment module II, Sections II 2.1 to II 2.6, of the dossier assessment Vedolizumab – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 October 2014). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative (...) and legally binding. IQWiG Reports – Commission No. A14-23 Vedolizumab – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-23 Version 1.0 Vedolizumab – Benefit assessment acc. to §35a Social Code Book V 13 October 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - 2 - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Vedolizumab – Benefit assessment according to §35a Social Code Book V Commissioning agency

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

150. Mirabegron - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A14-19 Version 1.0 Mirabegron – Benefit assessment acc. to §35a Social Code Book V 28 August 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Gerhard Jakse, Medical Faculty of Rhine-Westphalian (...) : full text view [online]. In: ClinicalTrials.gov. 16 September 2013 [accessed: 3 March 2014]. URL: http://ClinicalTrials.gov/show/NCT01043666. Extract of dossier assessment A14-19 Version 1.0 Mirabegron – Benefit assessment acc. to §35a Social Code Book V 28 August 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - 45 - References for English extract Please see full dossier assessment for full reference list. 1. Institute for Quality and Efficiency in Health Care. General Methods

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

151. Fingolimod (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Fingolimod (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Fingolimod (neues Anwendungsgebiet – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 26 September 2014). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports (...) – Commission No. A14-21 Fingolimod (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-21 Version 1.0 Fingolimod (new TI) – Benefit assessment acc. to §35a SGB V 26 September 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Fingolimod (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

152. Emergency Medicine Books

) These images are a random sampling from a Bing search on the term "Emergency Medicine Books." Click on the image (or right click) to open the source website in a new browser window. Related Studies (from Trip Database) Related Topics in General About FPnotebook.com is a rapid access, point-of-care medical reference for primary care and emergency clinicians. Started in 1995, this collection now contains 6656 interlinked topic pages divided into a tree of 31 specialty books and 728 chapters. Content (...) Emergency Medicine Books Emergency Medicine Books Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Emergency Medicine Books Emergency

2018 FP Notebook

153. Sports Medicine Books

." Click on the image (or right click) to open the source website in a new browser window. Related Studies (from Trip Database) Related Topics in General About FPnotebook.com is a rapid access, point-of-care medical reference for primary care and emergency clinicians. Started in 1995, this collection now contains 6656 interlinked topic pages divided into a tree of 31 specialty books and 728 chapters. Content is with systematic literature reviews and conferences. Although access to this website (...) Sports Medicine Books Sports Medicine Books Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Sports Medicine Books Sports Medicine

2018 FP Notebook

154. Improving Adherence to Therapy and Clinical Outcomes While Containing Costs: Opportunities From the Greater Use of Generic Medications: Best Practice Advice From the Clinical Guidelines Committee of the American College of Physicians Full Text available with Trip Pro

Improving Adherence to Therapy and Clinical Outcomes While Containing Costs: Opportunities From the Greater Use of Generic Medications: Best Practice Advice From the Clinical Guidelines Committee of the American College of Physicians Opportunities From the Greater Use of Generic Medications | Annals of Internal Medicine | American College of Physicians '); } '); })(); Sign in below to access your subscription for full content INDIVIDUAL SIGN IN | You will be directed to acponline.org (...) to register and create your Annals account INSTITUTIONAL SIGN IN | | Subscribe to Annals of Internal Medicine . You will be directed to acponline.org to complete your purchase. Search Clinical Guidelines | 5 January 2016 Improving Adherence to Therapy and Clinical Outcomes While Containing Costs: Opportunities From the Greater Use of Generic Medications: Best Practice Advice From the Clinical Guidelines Committee of the American College of Physicians Free Niteesh K. Choudhry, MD, PhD; Thomas D. Denberg

2015 American College of Physicians

155. 2018 Book List: A (non-medical) year in review

number score: I don’t know By Jeanne Lenzer An absolute must read, whether you are in medicine or not. Medical science has been broken in so many ways by the involvement of industry money. Using interesting stories about medical devices, this book chronicles many of those deficiencies. Arbitrary number score: 88 By Josiah Bancroft Not nearly as good as the first book (Senlin Ascends) but OK for a light, fun read. Arbitrary number score: 71 By Somerset Maugham I have considered this one of my favorite (...) 2018 Book List: A (non-medical) year in review 2018 Book List: A (non-medical) year in review - First10EM Search 2018 Book List: A (non-medical) year in review by | Published - Updated | I tend to read a lot. In previous years, one of the things I have found frustrating is forgetting which books I have already read when when hunting for my next read (especially with long series or authors with a huge number of titles). Therefore, this year I decided to keep track of the books I read. Looking

2018 First10EM

156. Responsible use of high-risk medical devices: the example of 3D printed medical devices

) Participation in scientific or experimental research as an initiator, principal investigator or researcher: Philip Tack (IWT Project ‘Roadmap’ about medical 3D Printing (part Health economy: PHD traject), Jan Schrooten (Projects KU Leuven – generative medicine / VLAIO feasibility assessment Antheron BV.B.A.), Stefaan Nijs (3D modelling in shoulder althea prof. (UZ Leuven – KU Leuven)) A grant, fees or funds for a member of staff or another form of compensation for the execution of research described above (...) EUDAMED European Databank on Medical Devices EUIPO EUnetHTA European Union Intellectual Property Office European Network for Health Technology Assessment EUTM DD DMCA FAMHP European Union Trade Mark Directive on the legal protection of designs Digital Millennium Copyright Act Federal Agency for Medicines and Health Products (FAGG-AFMPS) FDA Food and Drug Administration GDPR General Data Protection Regulation HSR HTA Health Services Research Health Technology Assessment IC IDEAL INAHTA Insurance

2018 Belgian Health Care Knowledge Centre

157. Apixaban (extension of approval) - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Apixaban (extension of approval) - Benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Apixaban (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 26 November 2014). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports (...) – Commission No. A14-28 Apixaban (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-28 Version 1.0 Apixaban (new therapeutic indication) – Benefit assessment acc. to §35a SGB V 26 Nov 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Apixaban (new therapeutic indication) – Benefit assessment according to §35a SGB V

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

158. Dolutegravir - Benefit assessment according to §35a Social Code Book V (dossier assessment)

No.: A14-08 Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A14-08 Version 1.0 Dolutegravir – Benefit assessment acc. to §35a Social Code Book V 12 May 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Ingo Niemetz, diabetological practice (...) randomized controlled trial SAE serious adverse event SDM symptom distress module SGB Sozialgesetzbuch (Social Code Book) SOC Medical Dictionary for Regulatory Activities System Organ Class SPC Summary of Product Characteristics TDF tenofovir Extract of dossier assessment A14-08 Version 1.0 Dolutegravir – Benefit assessment acc. to §35a Social Code Book V 12 May 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - 1 - 2 Benefit assessment 2.1 Executive summary of the benefit assessment

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

159. Ipilimumab (new therapeutic indication) - Benefit assessment according to § 35a Social Code Book V (dossier assessment)

Ipilimumab (new therapeutic indication) - Benefit assessment according to § 35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ipilimumab (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status 13 March 2014). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports (...) – Commission No. A13-44 Ipilimumab (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A13-44 Version 1.0 Ipilimumab (new TI) – Benefit assessment acc. to §35a Social Code Book V 13 March 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ipilimumab (new therapeutic indication) – Benefit assessment according to §35a Social Code Book

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

160. Propranolol - Benefit assessment according to §35a Social Code Book V (dossier assessment)

No.: A14-29 Address of publisher: Institute for Quality and Efficiency in Health Care Im Mediapark 8 (KölnTurm) 50670 Cologne Germany Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet: www.iqwig.de Extract of dossier assessment A14-29 Version 1.0 Propranolol – Benefit assessment acc. to §35a Social Code Book V 26 November 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Medical and scientific advice: ? Wolfgang Rascher, University Hospital (...) Medical Dictionary for Regulatory Activities PT MedDRA Preferred Term RCT randomized controlled trial SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SOC MedDRA System Organ Class SPC Summary of Product Characteristics Extract of dossier assessment A14-29 Version 1.0 Propranolol – Benefit assessment acc. to §35a Social Code Book V 26 November 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - 1 - 2 Benefit assessment 2.1 Executive summary of the benefit assessment

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

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