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Clinical Index of Stable Febrile Neutropenia

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41. Adalimumab (Hefiya) - Juvenile Rheumatoid Arthritis, Hidradenitis Suppurativa, Psoriasis, Ankylosing Spondylitis, Uveitis

Disease or condition 12 2.2 Quality aspects 14 2.2.1 Introduction 14 2.2.2 Active Substance 14 2.2.3 Finished Medicinal Product 18 2.2.4 Discussion on chemical, pharmaceutical and biological aspects 28 2.2.5 Conclusions on the chemical, pharmaceutical and biological aspects 28 2.2.6 Recommendation(s) for future quality development 28 2.3 Non-clinical aspects 28 2.3.1 Pharmacology 29 2.3.2 Pharmacokinetics 30 2.3.3 Toxicology 31 2.3.4 Ecotoxicity/environmental risk assessment 32 2.3.5 Discussion on non (...) -clinical aspects 32 2.3.6 Conclusion on the non-clinical aspects 33 2.4 Clinical aspects 33 2.4.1 Introduction 33 2.4.2 Pharmacokinetics 36 2.4.3 Pharmacodynamics 51 2.4.4 Discussion on clinical pharmacology 51 2.4.5 Conclusions on clinical pharmacology 53 2.5 Clinical efficacy 54 2.5.1 Main study GP17-301 54 2.5.2 Discussion on clinical efficacy 80 2.5.3 Conclusions on the clinical efficacy 83 2.6 Clinical safety 83 2.6.1 Discussion on clinical safety 102 2.6.2 Conclusions on the clinical safety 104

2018 European Medicines Agency - EPARs

42. Adalimumab (Halimatoz) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Hidradenitis Suppurativa, Psoriasis, Ankylosing Spondylitis, Uveitis

Scientific discussion 12 2.1 Problem statement 12 2.1.1 Disease or condition 12 2.2 Quality aspects 14 2.2.1 Introduction 14 2.2.2 Active Substance 14 2.2.3 Finished Medicinal Product 18 2.2.4 Discussion on chemical, pharmaceutical and biological aspects 28 2.2.5 Conclusions on the chemical, pharmaceutical and biological aspects 28 2.2.6 Recommendation(s) for future quality development 28 2.3 Non-clinical aspects 29 2.3.1 Pharmacology 29 2.3.2 Pharmacokinetics 30 2.3.3 Toxicology 31 2.3.4 Ecotoxicity (...) /environmental risk assessment 32 2.3.5 Discussion on non-clinical aspects 33 2.3.6 Conclusion on the non-clinical aspects 33 2.4 Clinical aspects 34 2.4.1 Introduction 34 2.4.2 Pharmacokinetics 36 2.4.3 Pharmacodynamics 51 2.4.4 Discussion on clinical pharmacology 51 2.4.5 Conclusions on clinical pharmacology 53 2.5 Clinical efficacy 54 2.5.1 Main study GP17-301 54 2.5.2 Discussion on clinical efficacy 80 2.5.3 Conclusions on the clinical efficacy 83 2.6 Clinical safety 83 2.6.1 Discussion on clinical

2018 European Medicines Agency - EPARs

43. Plitidepsin (Aplidin) - Multiple Myeloma

2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 24 2.2.6. Recommendations for future quality development 24 2.3. Non-clinical aspects 24 2.3.1. Introduction 24 2.3.2. Pharmacology 24 2.3.3. Pharmacokinetics 35 2.3.4. Toxicology 37 2.3.5. Ecotoxicity/environmental risk assessment 43 2.3.6. Discussion on non-clinical aspects 44 2.3.7. Conclusion on the non-clinical aspects 45 2.4. Clinical aspects 45 2.4.1. Introduction 45 2.4.2. Pharmacokinetics 47 2.4.3. Pharmacodynamics 56 (...) 2.4.4. Discussion on clinical pharmacology 59 2.4.5. Conclusions on clinical pharmacology 62 2.5. Clinical efficacy 62 2.5.1. Dose response study(ies) 62 2.5.2. Dose finding studies 62 2.5.3. Main study 63 2.5.4. Supportive studies 95 2.5.5. Discussion on clinical efficacy 98 2.5.6. Conclusions on the clinical efficacy 101 2.6. Clinical safety 101 2.6.1. Discussion on clinical safety 125 2.6.2. Conclusions on the clinical safety 128 2.7. Risk Management Plan 128 2.8. Pharmacovigilance 133 2.9. New

2018 European Medicines Agency - EPARs

44. 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

45. 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

46. 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

47. 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

48. 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

49. 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

50. Axicabtagene ciloleucel (Yescarta) - diffuse large B-cell lymphoma (DLBCL); primary mediastinal large B-cell lymphoma (PMBCL)

dysfunction (e.g. hepatic, renal, cardiac, and pulmonary). In addition worsening of underlying organ pathologies can occur in the setting of CRS. Patients with medically significant cardiac dysfunction should be managed by standards of critical care and measures such as echocardiography should be considered. Diagnosis of CRS requires excluding alternate causes of systemic inflammatory response, including infection. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum (...) 1000 mg intravenously per day for 2 more days; if improves, then manage as above. Administer methylprednisolone 1000 mg intravenously per day for 3 days; if improves, then manage as above. Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis. Infections and febrile neutropenia Serious infections have been very commonly observed with YESCARTA (see section 4.8). Patients should be monitored for signs and symptoms of infection before, during, and after YESCARTA

2018 European Medicines Agency - EPARs

51. Guideline on the prudent prescription of antibiotics in the dental office

Guideline on the prudent prescription of antibiotics in the dental office KCE REPORT 332 GUIDELINE ON THE PRUDENT PRESCRIPTION OF ANTIBIOTICS IN THE DENTAL OFFICE 2020 www.kce.fgov.be KCE REPORT 332 GOOD CLINICAL PRACTICE GUIDELINE ON THE PRUDENT PRESCRIPTION OF ANTIBIOTICS IN THE DENTAL OFFICE ROOS LEROY, JOLYCE BOURGEOIS, LEEN VERLEYE, DOMINIQUE DECLERCK, PIETER DEPUYDT, ANOUK ELOOT, JOANA C CARVALHO, WIM TEUGHELS, RITA CAUWELS, JULIAN LEPRINCE, SELENA TOMA, KATLEEN MICHIELS, SAM ARYANPOUR (...) ) Participation in scientific or experimental research as an initiator, principal investigator or researcher: Carl Brabants (Clinical Outcome following Total Hip Arthroplasty with SMF-stem: A prospective consecutive series, multicentre clinical study (Smith & Nephew)), Julian Leprince (Clinical study about irreversible pulpitis, see clinicaltrials.gov), Jeroen Neyt (Topography and comparative study microbiome in periprosthetic infections), Wim Teughels (PI in studies on the use of probiotics and guidance

2020 Belgian Health Care Knowledge Centre

52. 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)

53. 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

54. The EAU – EANM – ESTRO – ESUR – SIOG Guidelines on Prostate Cancer

., et al. The percentage of prostate-specific antigen (PSA) isoform [-2]proPSA and the Prostate Health Index improve the diagnostic accuracy for clinically relevant prostate cancer at initial and repeat biopsy compared with total PSA and percentage free PSA in men aged clinical trial. JAMA, 1998. 279: 1542. 148. Huang, Y., et al. Value of free/total prostate-specific antigen (f/t PSA) ratios for prostate cancer detection in patients with total serum prostate-specific antigen between 4 and 10 ng/mL: A meta-analysis. Medicine (Baltimore), 2018. 97: e0249. 149. Loeb, S., et al. The Prostate Health Index: a new test for the detection of prostate cancer. Ther

2020 European Association of Nuclear Medicine

55. 5th ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 5) Full Text available with Trip Pro

/A 95% ABC patients who desire to work or need to work for financial reasons should have the opportunity to do so, with needed and reasonable flexibility in their working schedules to accommodate continuous treatment and hospital visits. Expert opinion/A 100% ABC patients with stable disease being treated as a ‘chronic condition’ should have the option to undergo breast reconstruction if clinically appropriate. Expert opinion/B 82% In ABC patients with long-standing stable disease or complete (...) 5th ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 5) 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5)† - Annals of Oncology Go search Powered By Mendeley Share on 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) † F. Cardoso Correspondence Correspondence to: Dr Fatima Cardoso, Breast Unit, Champalimaud Clinical Center, Av. De Brasília s/n, 1400-038 Lisbon, Portugal Affiliations Breast Unit

2020 European Society for Medical Oncology

56. Managing cancer patients during the COVID-19 pandemic: An ESMO Interdisciplinary Expert Consensus

workers screen positive for fever or respiratory symptoms, the consensus advice is firmly for swab and abstain from work/home quarantine until swab is negative (16, 17). We suggest implementing serological evaluations of established validity in healthcare workers in order to depict an epidemiological landscape of the pandemic. Is there any different value/indication for the usage of granulocyte-colony stimulating factors (G-CSF) during the COVID pandemic? STATEMENT 6: To lower the risk of febrile (...) neutropenia, consider expanding the indication of G-CSF for patients with intermediate (10%-20%) and high risk for febrile neutropenia (>20%), and specifically for elderly patients with comorbidities. Given the COVID-19 infection risk specifically, in patients with solid tumors not treated with curative intent, one should consider equally effective treatments unlikely to induce febrile neutropenia. There should be clear evidence to support using chemotherapy regimens with higher neutropenia risk. Moreover

2020 European Society for Medical Oncology

57. 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)

58. 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

59. 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

60. 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

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