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Clinical Index of Stable Febrile Neutropenia

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41. Ocrelizumab (Ocrevus) - multiple sclerosis

ATA anti-therapeutic antibody AUC area under the concentration-time curve AUC last area under the concentration-time curve from time 0 to the last measurable concentration AUC inf area under the concentration-time curve from time 0 to infinity AUC t area under the concentration-time curve within a dosing interval BCC basal cell carcinoma BLA Biologics License Application BLQ below the limit of quantification BMI body mass index BSA body surface area CCOD clinical cut-off date CDC complement (...) and pathogenesis 14 2.1.4. Clinical presentation and diagnosis 14 2.1.5. Management 15 2.2. Quality aspects 17 2.2.1. Introduction 17 2.2.2. Active Substance 17 2.2.3. Finished Medicinal Product 21 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 24 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 25 2.2.6. Recommendations for future quality development 25 2.3. Non-clinical aspects 25 2.3.1. Introduction 25 2.3.2. Pharmacology 25 2.3.3. Pharmacokinetics 27 2.3.4

2018 European Medicines Agency - EPARs

42. Letermovir (Prevymis) - to prevent illness caused by cytomegalovirus (CMV) in adults having an allogeneic haematopoietic stem cell transplant

. Problem statement 8 2.2. Quality aspects 9 2.2.1. Introduction 9 2.2.2. Active Substance 9 2.2.3. Finished Medicinal Product 12 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 17 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 17 2.2.6. Recommendation(s) for future quality development 17 2.3. Non-clinical aspects 18 2.3.1. Introduction 18 2.3.2. Pharmacology 18 2.3.3. Pharmacokinetics 20 2.3.4. Toxicology 22 2.3.5. Ecotoxicity/environmental risk (...) assessment 29 2.3.6. Discussion on non-clinical aspects 31 2.3.7. Conclusion on the non-clinical aspects 33 2.4. Clinical aspects 34 2.4.1. Introduction 34 2.4.2. Pharmacokinetics 37 2.4.3. Pharmacodynamics 52 2.4.4. Discussion on clinical pharmacology 57 2.4.5. Conclusions on clinical pharmacology 63 2.5. Clinical efficacy 64 2.5.1. Dose response studies 64 2.5.2. Main study 66 2.5.3. Discussion on clinical efficacy 95 2.5.4. Conclusions on the clinical efficacy 97 2.6. Clinical safety 97 2.6.1

2018 European Medicines Agency - EPARs

43. Bevacizumab (Mvasi) - Cancer, colon, breast, lung, kidney, ovary, cervix

, pharmaceutical and biological aspects 26 2.2. Non-clinical aspects 26 2.2.1. Introduction 26 2.2.2. Pharmacology 27 2.2.3. Pharmacokinetics 32 2.2.4. Toxicology 34 2.2.5. Ecotoxicity/environmental risk assessment 36 2.2.6. Discussion on non-clinical aspects 36 2.2.7. Conclusion on the non-clinical aspects 37 2.3. Clinical aspects 37 2.3.1. Introduction 37 2.3.2. Pharmacokinetics 38 2.3.3. Pharmacodynamics 43 2.3.4. Immunogenicity 44 2.3.5. Discussion on clinical pharmacology 44 2.3.6. Conclusions on clinical (...) pharmacology 45 2.4. Clinical efficacy 46 2.4.1. Dose response study(ies) 46 2.4.2. Main study(ies) 46 2.4.3. Discussion on clinical efficacy 62 2.4.4. Conclusions on the clinical efficacy 64 2.5. Clinical safety 65 Immunological events 78 2.5.1. Discussion on clinical safety 80 2.5.2. Conclusions on the clinical safety 82 2.6. Risk Management Plan 82 2.7. Pharmacovigilance 86 2.8. Product information 86 2.8.1. User consultation 86 2.8.2. Additional monitoring 86 Assessment report EMA/798844/2017 Page 2/91

2018 European Medicines Agency - EPARs

44. Peramivir (Alpivab) - Influenza, Human

aminotransferase AP Alkaline phosphatase ARDS Acute respiratory distress syndrome AST Aspartate aminotransferase AUC Area under the time concentration curve BID Twice daily BMI Body mass index CDC Centers for Disease Control and Prevention CFB Change from baseline CI Confidence interval CL Clearance CLcr Creatinine clearance Cmax Maximum concentration CSR Clinical study report CK / CPK Creatine phosphokinase COPD Chronic obstructive pulmonary disease CYP Cytochrome ECDC European Centre for Disease Prevention (...) inflammation and oedema of the larynx, trachea, and bronchi; mucosal biopsies show lymphocytic and histiocytic inflammatory infiltrate and desquamation (Walsh et al., 1961). The viral neuraminidase cleaves sialic acid groups from glycoproteins and facilitates viral escape from infected cells, making it possible for daughter virions to infect new host cells. 2.1.4. Clinical presentation, diagnosis and stage/prognosis Typical influenza illness is characterised by abrupt onset of fever, headache, myalgia

2018 European Medicines Agency - EPARs

45. Gemtuzumab ozogamicin (Mylotarg) - Leukemia, Myeloid, Acute

factors, screening tools/prevention 9 2.1.3. Biologic features 9 2.1.4. Clinical presentation, diagnosis and stage/prognosis 9 2.1.5. Management 9 2.2. Quality aspects 11 2.2.1. Introduction 11 2.2.2. Active Substance 12 2.2.3. Finished Medicinal Product 18 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 19 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 20 2.2.6. Recommendation(s) for future quality development 21 2.3. Non-clinical aspects 21 2.3.1 (...) . Introduction 21 2.3.2. Pharmacology 21 2.3.3. Pharmacokinetics 28 2.3.4. Toxicology 31 2.3.5. Ecotoxicity/environmental risk assessment 47 2.3.6. Discussion on non-clinical aspects 49 2.3.7. Conclusion on the non-clinical aspects 51 2.4. Clinical aspects 51 2.4.1. Introduction 51 2.4.2. Pharmacokinetics 55 2.4.3. Pharmacodynamics 60 2.4.4. Discussion on clinical pharmacology 63 2.4.5. Conclusions on clinical pharmacology 65 2.5. Clinical efficacy 65 2.5.1. Dose response studies 65 2.6. Main study

2018 European Medicines Agency - EPARs

46. Velmanase alfa (Lamzede) - alpha-Mannosidosis

+44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure 6 1.1. Submission of the dossier 6 1.2. Steps taken for the assessment of the product 8 2. Scientific discussion 9 2.1. Problem statement 9 2.1.1. Disease or condition 9 2.1.2. Epidemiology 9 2.1.3. Aetiology and pathogenesis 9 2.1.4. Clinical presentation (...) , diagnosis and prognosis 9 2.1.5. Management 10 2.2. Quality aspects 12 2.2.1. Introduction 12 2.2.2. Active Substance 12 2.2.3. Finished Medicinal Product 17 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 19 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 20 2.3. Non-clinical aspects 20 2.3.1. Introduction 20 2.3.2. Pharmacology 20 2.3.3. Pharmacokinetics 26 2.3.4. Toxicology 27 2.3.5. Ecotoxicity/environmental risk assessment 33 2.3.6. Discussion on non

2018 European Medicines Agency - EPARs

47. Prevention and Control of Methecillin-Resistant Staphylcoccus Aureus (MRSA)

hygiene is concentrated in activities known as the five moments for hand hygiene www.who.int/gpsc/tools/Five_moments/en/index. html (35). All senior medical, nursing, midwifery, allied health professional and administrative personnel, whose staff have clinical involvement, must ensure that staff understand the importance of hand hygiene, are familiar with, adhere to the national recommendations and participate in hand hygiene audit. Another study has highlighted the role of patients (...) Prevention and Control of Methecillin-Resistant Staphylcoccus Aureus (MRSA) Prevention and Control Methicillin-Resistant Staphylococcus aureus (MRSA) National Clinical Guideline No. 2 December 2013Guideline Development Group The Prevention and Control of Methicillin-resistant Staphylococcus aureus (MRSA) National Clinical Guideline was developed by the Royal College of Physicians Ireland (RCPI) Clinical Advisory Group on healthcare associated infections (HCAI) - Subgroup MRSA Guideline

2019 National Clinical Guidelines (Ireland)

48. Palbociclib (Ibrance) - hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer

6.4%), decreased appetite (16% versus 8.1%), dyspnoea (13% versus 8.7%), nasopharyngitis (13% versus 8.1%) stomatitis (13% versus 2.9%), pyrexia (13% versus 5.2%), oropharyngeal pain (12% versus 7.0%), insomnia (11% versus 8.1%) and rash (11% versus 5.2%), respectively. 2 Summary of clinical effectiveness issues Palbociclib was the first CDK4/6 inhibitor licensed for treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer. In addition to palbociclib, there are now two (...) should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist. 1 Dosing Information The recommended dose is 125mg of palbociclib orally once daily for 21 consecutive days followed by seven days off treatment to comprise a complete cycle of 28 days. The capsule should be swallowed whole and taken with food. The treatment with palbociclib should be continued as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs. When co-administered

2019 Scottish Medicines Consortium

49. Sepsis Management

but not specific and sepsis represents a continuum through sepsis, severe sepsis and septic shock with increasing mortality as the disease progresses. It can be difficult to recognise, for example, up to 60% of patients with sepsis may present without a febrile response and the presenting complaint in the elderly may be a fall. (15) As Niccolo Machiavelli stated in The Prince in 1513: “…as the physicians say it happens in hectic fever, that in the beginning of the malady it is easy to cure but difficult (...) Sepsis Management Sepsis Management National Clinical Guideline No. 6 November 2014National Clinical Guideline No. 6 ISSN 2009-6259 Published November 2014 Supplementary methodological information added (page 57) February 2015 Disclaimer The Guideline Development Group’s expectation is that healthcare staff will use clinical judgement, medical, nursing and midwifery knowledge in applying the general principles and recommendations contained in this document. Recommendations may

2019 National Clinical Guidelines (Ireland)

50. Prostate Cancer

characteristics of prostate cancer. Prostate, 2010. 70: 10. 144. Auprich, M., et al. Contemporary role of prostate cancer antigen 3 in the management of prostate cancer. Eur Urol, 2011. 60: 1045. 145. Nicholson, A., et al. The clinical effectiveness and cost-effectiveness of the PROGENSA(R) prostate cancer antigen 3 assay and the Prostate Health Index in the diagnosis of prostate cancer: a systematic review and economic evaluation. Health Technol Assess, 2015. 19: 1. 146. Wei, J.T., et al. Can urinary PCA3 (...) Broeck T., et al. A systematic review of oncological effectiveness and harms of primary local interventions for high-risk localized and locally advanced prostate cancer. PROSPERO International prospective register of systematic reviews, 2017. CRD42017078862 8. Willemse, P.M., et al. Systematic review of deferred treatment with curative intent for localised prostate cancer to explore heterogeneity of definitions, thresholds and criteria and clinical effectiveness. PROSPERO International prospective

2019 European Association of Urology

51. Muscle-invasive and Metastatic Bladder Cancer

., Sesterhenn I.A., editors. 2004, IARCC Press: Lyon. 58. Kapur, P., et al. Primary adenocarcinoma of the urinary bladder: value of cell cycle biomarkers. Am J Clin Pathol, 2011. 135: 822. 59. Ploeg, M., et al. Clinical epidemiology of nonurothelial bladder cancer: analysis of the Netherlands Cancer Registry. J Urol, 2010. 183: 915. 60. Beltran, A.L., et al. Clinicopathological characteristics and outcome of nested carcinoma of the urinary bladder. Virchows Arch, 2014. 465: 199. 61. Mukesh, M., et al. Small (...) , 2003. 169: 955. 66. Fossa, S.D., et al. Clinical significance of the “palpable mass” in patients with muscle-infiltrating bladder cancer undergoing cystectomy after pre-operative radiotherapy. Br J Urol, 1991. 67: 54. 67. Wijkstrom, H., et al. Evaluation of clinical staging before cystectomy in transitional cell bladder carcinoma: a long-term follow-up of 276 consecutive patients. Br J Urol, 1998. 81: 686. 68. Ploeg, M., et al. Discrepancy between clinical staging through bimanual palpation

2019 European Association of Urology

52. MammaPrint test for personalised management of adjuvant chemotherapy decisions in early breast cancer

on the stage of the tumour at the time of diagnosis. Five-year breast cancer survival in Belgium is 100% for TNM Clinical Stage 0, 99.4% for stage I and falls to 28.0% for Stage IV. 4 More sophisticated tools to assess the likely prognosis of breast cancer, based on several classifications and patient characteristics have been developed in the recent years, some of them computerized, such as the Adjuvant!Online c , PREDICT d or the Nottingham Prognostic Index (NPI) e . Although different, most (...) considered. These included the Nottingham Prognosis Index (NPI) 18 or international clinical guidelines such as St Gallen 21, 27 and the US National Institutes of Health (NIH) guidelines 25 , or an approach where all patients received chemotherapy. 16 . The study by Ward et al. 18 referred to “clinical” practice as their main comparator, which combined the use of NPI, A!O and other prognostic information. The three studies comparing MammaPrint ® to other gene profiling tests, used in all cases Oncotype

2018 Belgian Health Care Knowledge Centre

53. Guidelines for the Management of Genital Herpes in New Zealand

Tests 9 Key Information to Discuss with a Patient Who Asks for a Blood Test 9 Table 1: Interpreting Blood Test Results 10 MANAGEMENT OF CLINICAL EPISODES OF GENITAL HERPES 10 Management of First Clinical Episode 12 Treatment algorithm – Management of First Episode of Genital Herpes 13 Treatment of First Episode Genital Herpes 14 Management of Recurrent Episodes of Genital Herpes 15 Treatment of Recurrent Genital Herpes 16 Genital Herpes in Immunocompromised Individuals 17 Treatment algorithm (...) – Management of Recurrent Episodes of Genital Herpes 18 GENITAL HERPES IN PREGNANCY 18 Maternal Fetal Transmission 19 Use of Antivirals in Pregnancy and Breastfeeding 19 Mode of Delivery 21 Special Situations in Pregnancy 21 Prevention of HSV in the Neonate 21 Summary of Clinical Management of First Episode Genital Herpes in Pregnancy 22 Treatment algorithm – Management of Women with Suspected Genital Herpes in Pregnancy 23 First Episode Genital Herpes: First and Second Trimester Acquisition 23 First

2017 New Zealand Sexual Health Society

54. Muscle-invasive and Metastatic Bladder Cancer

., Sesterhenn I.A., editors. 2004, IARCC Press: Lyon. 58. Kapur, P., et al. Primary adenocarcinoma of the urinary bladder: value of cell cycle biomarkers. Am J Clin Pathol, 2011. 135: 822. 59. Ploeg, M., et al. Clinical epidemiology of nonurothelial bladder cancer: analysis of the Netherlands Cancer Registry. J Urol, 2010. 183: 915. 60. Beltran, A.L., et al. Clinicopathological characteristics and outcome of nested carcinoma of the urinary bladder. Virchows Arch, 2014. 465: 199. 61. Mukesh, M., et al. Small (...) , 2003. 169: 955. 66. Fossa, S.D., et al. Clinical significance of the “palpable mass” in patients with muscle-infiltrating bladder cancer undergoing cystectomy after pre-operative radiotherapy. Br J Urol, 1991. 67: 54. 67. Wijkstrom, H., et al. Evaluation of clinical staging before cystectomy in transitional cell bladder carcinoma: a long-term follow-up of 276 consecutive patients. Br J Urol, 1998. 81: 686. 68. Ploeg, M., et al. Discrepancy between clinical staging through bimanual palpation

2018 European Association of Urology

55. Antimicrobial Prophylaxis for Adult Patients with Cancer-Related Immunosuppression

physicians, nurses, and advanced practice providers who may treat patients with immunosuppression resulting from cancer treatment. Methods An Expert Panel convened to update clinical practice guideline recommendations on the basis of a systematic review of the medical literature. Key Recommendations A summary of antimicrobial prophylaxis recommendations can be found here and in . Antimicrobial prophylaxis: Recommendation 1.1: Risk of febrile neutropenia (FN) should be systematically assessed (...) and strength of recommendations, slide sets, and clinical tools and resources, at . Patient information is available at . Related ASCO Guidelines Recommendations for the Use of WBC Growth Factors Update. ( ) Central Venous Catheter Care for the Patient With Cancer. ( ) Hepatitis B Virus Screening for Patients With Cancer Before Therapy. Outpatient Management of Fever and Neutropenia in Adults Treated for Malignancy. © 2018 by American Society of Clinical Oncology R.A.T. and C.R.F. were Expert Panel Co

2018 American Society of Clinical Oncology Guidelines

56. Treatment for Bipolar Disorder in Adults: A Systematic Review

for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients. This report is made available to the public under the terms of a licensing agreement between the author and the Agency for Healthcare Research and Quality. This report may be used (...) and reprinted without permission except those copyrighted materials that are clearly noted in the report. Further reproduction of those copyrighted materials is prohibited without the express permission of copyright holders. AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied. This report may

2018 Effective Health Care Program (AHRQ)

57. Drug Therapy for Early Rheumatoid Arthritis: A Systematic Review Update

. The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent (...) of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied. This report may periodically be assessed for the currency of conclusions. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site

2018 Effective Health Care Program (AHRQ)

58. Obinutuzumab (Gazyvaro) - In combination with chemotherapy, followed by maintenance therapy in patients achieving a response, for the treatment of patients with previously untreated advanced follicular lymphoma (FL).

%, neutropenia 46% versus 40%, thrombocytopenia 6.1% versus 2.7%, infections, 20% versus 16%, and second malignancies 4.7% versus 2.7%. Deaths considered to be due to adverse events occurred in 4.0% (24/595) of patients treated with obinutuzumab versus 3.4% (20/597) of patients treated with rituximab. 2 Summary of clinical effectiveness issues Follicular lymphoma is a subtype of indolent NHL, which comprises about 70% of indolent NHL and about 20% to 25% of all new NHL. It is a mature B-cell neoplasm (...) to as higher) risk disease, follicular lymphoma international prognostic index (FLIPI) =2. The key evidence to support the indication under review is from GALLIUM, an ongoing, multicentre, phase III, open-label randomised study comparing obinutuzumab plus chemotherapy followed by obinutuzumab maintenance, with rituximab plus chemotherapy followed by rituximab maintenance, in 1,401 adults with previously untreated, histologically documented, advanced indolent non-Hodgkin’s lymphoma (NHL). A total of 1,202

2018 Scottish Medicines Consortium

59. Prostate Cancer

characteristics of prostate cancer. Prostate, 2010. 70: 10. 144. Auprich, M., et al. Contemporary role of prostate cancer antigen 3 in the management of prostate cancer. Eur Urol, 2011. 60: 1045. 145. Nicholson, A., et al. The clinical effectiveness and cost-effectiveness of the PROGENSA(R) prostate cancer antigen 3 assay and the Prostate Health Index in the diagnosis of prostate cancer: a systematic review and economic evaluation. Health Technol Assess, 2015. 19: 1. 146. Wei, J.T., et al. Can urinary PCA3 (...) Broeck T., et al. A systematic review of oncological effectiveness and harms of primary local interventions for high-risk localized and locally advanced prostate cancer. PROSPERO International prospective register of systematic reviews, 2017. CRD42017078862 8. Willemse, P.M., et al. Systematic review of deferred treatment with curative intent for localised prostate cancer to explore heterogeneity of definitions, thresholds and criteria and clinical effectiveness. PROSPERO International prospective

2018 European Association of Urology

60. Rituximab (Blitzima) - follicular lymphoma and diffuse large B cell non-Hodgkin?s lymphoma OR chronic lymphocytic leukaemia OR granulomatosis with polyangiitis (GPA or Wegener?s granulomatosis) and microscopic polyangiitis (MPA)

Circular dichroism Clinical disease activity index CDC Complement-dependent cytotoxicity CHO CHOP Chinese Hamster Ovary Cyclophosphamide, doxorubicin, vincristine, prednisolone CI Confidence interval CIPT CL Critical In-process Test Total body clearance CLL Chronic lymphocytic leukaemia CLT1 Cmax CELLTRION Plant I Maximum serum concentration after the second infusion CLT2 Cmax, 1 CELLTRION Plant II Maximum serum concentration after the first infusion Cmin Minimum serum concentration immediately before (...) Electrochemiluminescence Fc?RI ESR Fc gamma receptor R1 (CD64) Erythrocyte sedimentation rate Assessment report EMA/CHMP/421793/2017 Page 5/161 Fc?RIIIa-V EULAR Fc gamma receptor 3a (CD16a) V type receptor European league against rheumatism FcRn GCP neonatal Fc receptor Good clinical practice GI Gastrointestinal GMP GPA Good Manufacturing Practice Granulomatosis with polyangiitis HACA Human anti-chimeric antibodies HAQ Health assessment questionnaire disability index HBV Hepatitis B virus HCP HMW Host Cell Protein

2017 European Medicines Agency - EPARs

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