PDF | Background: Esketamine nasal spray was recently approved for treatment-resistant depression (TRD). Spravato (esketamine) nasal spray is used for treatment-resistant depression and major depressive disorder (MDD) with acute suicidal ideation or behavior. Kalydeco (ivacaftor) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients ages 4 months and older who have one mutation in the CFTR gene that is responsive to ivacaftor. • Veklury® [remdesivir]. FDA Approved Indication(s) Spravato is indicated for the treatment of treatment-resistant depression (TRD) in adults, in conjunction with an oral antidepressant. Osimertinib for untreated EGFR mutation-positive non-small-cell lung cancer [NICE guidance]. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Hydroxycarbamide for the prevention of vaso-occlusive complications of sickle-cell disease in patients over 2 years of age [AWMSG guidance]. • Tivozanib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice]. Mercaptamine [update to dosing for nephropathic cystinosis]. Immunisation schedule: updated National flu immunisation programme in-line with Public Health England recommendations. New Indication Approved: March 5, 2021 Esketamine, the S-enantiomer of ket - amine, is a non-selective, non-competi- ... the dose regimen being dependent on age, ancestry and response ... minutes after dosing, and the patient monitored by a healthcare professional until they are considered clinically stable, in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults Entrectinib for treating ROS1-positive advanced non-small-cell lung cancer [NICE guidance]. Brolucizumab for the treatment of adults with neovascular (wet) age-related macular degeneration [SMC guidance]. Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma. Subjects in the treatment arm received esketamine on day 1 of the treatment phase with a 56-mg dose. Gilteritinib for treating relapsed or refractory acute myeloid leukaemia [NICE guidance]. All rights reserved. New Dosage Regimen: September 3, 2020 Date of Original Approval: September 18, 2014. New Indication Approved: July 31, 2020 Rapivab (peramivir) is an influenza virus neuraminidase inhibitor indicated for the treatment of acute uncomplicated influenza. New Indication Approved: January 15, 2021 Speed and safety: Provides rapid reference to essential information on the selection of safe and effective medicines for individual patients, Evidence Grading: As part of NICE accreditation recommendations, BNF content is now evidence graded to reflect the strength of evidence behind them, increasing transparency to support healthcare professionals with clinical decision making, Always up-to-date: The content is revalidated, revised, and updated on a monthly basis, making sure you have access to the very latest prescribing knowledge, Worldwide credibility: The BNF uses clinical evidence from a diverse range of sources and a network of experts, giving you the confidence to select medicines safely, *based on average data in the last 12 months. Quetiapine: Clozapine and other antipsychotics: monitoring blood concentrations for toxicity [MHRA/CHM advice]. Date of Original Approval: December 9, 1991. • Upadacitinib for treating severe rheumatoid arthritis [NICE guidance]. Influenza: updated guidance on management. Hydroxycarbamide for the prevention of vaso-occlusive complications of sickle-cell disease in patients over 2 years of age [SMC guidance]. Participants >= 65 years old will start at a dose of 28 mg on Day 1. Avelumab with axitinib for untreated advanced renal cell carcinoma [NICE guidance]. Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is an inhaled corticosteroid, long-acting muscarinic antagonist (LAMA), and long-acting beta2-adrenergic agonist (LABA) combination indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), and the maintenance treatment of asthma in patients aged 18 years and older. Pertuzumab in combination with trastuzumab and chemotherapy for the treatment of adults with HER2-positive early breast cancer [SMC guidance]. Patient Population Altered: December 4, 2020 British National Formulary February 2021 Update, British National Formulary January 2021 Update, British National Formulary December 2020 Update, British National Formulary November 2020 Update, British National Formulary October 2020 Update, British National Formulary September 2020 Update. Patient Population Altered: January 28, 2021 • Vandetanib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice]. Pembrolizumab with axitinib for untreated advanced renal cell carcinoma [NICE guidance]. Nivolumab for advanced squamous non-small-cell lung cancer after chemotherapy [NICE guidance]. Pembrolizumab [dosing information updated]. Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: New Indication Approved: November 16, 2020 Gavreto (pralsetinib) is an oral selective RET kinase inhibitor for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion- positive non-small cell lung cancer (NSCLC), and adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC). Dosing. Patient Population Altered: December 18, 2020 Deleted Monographs: Conjugated oestrogens with bazedoxifene acetate; Fenticonazole nitrate; Nedocromil sodium; Rolapitant. Aripiprazole: Clozapine and other antipsychotics: monitoring blood concentrations for toxicity [MHRA/CHM advice]. Caplacizumab for the treatment of adults with acquired thrombotic thrombocytopenic purpura [SMC guidance]. • Trastuzumab emtansine (Kadcyla®) as a single agent, for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy [SMC guidance]. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. Sodium zirconium cyclosilicate for the treatment of adults with hyperkalaemia [SMC guidance]. For BNF print editions – list of medicinal preparations (Nurse Prescribers’ Formulary (NPF)) updated with indications for use by Community Practitioner Nurse Prescribers and cross-references to BNF monographs. for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. • Enerzair Breezhaler® [mometasone furoate with glycopyrronium bromide and indacaterol]. Epidiolex (cannabidiol) is a prescription pharmaceutical formulation of highly-purified, marijuana plant-derived cannabidiol (CBD) indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex. For further details on changes in the BNF click on http://www.medicinescomplete.com/mc/bnf/current/PHP107699-changes.htm. Cannabidiol with clobazam for therapy of seizures associated with Dravet syndrome [SMC guidance]. • Quinolones (systemic and inhaled fluoroquinolones): small risk of heart valve regurgitation; consider other therapeutic options first in patients at risk [MHRA/CHM advice] (advice in ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, ofloxacin; see example in ciprofloxacin). Gilteritinib for the treatment of adults who have relapsed or refractory acute myeloid leukaemia with a FLT3 mutation [SMC guidance]. Hepatitis A vaccine: updated guidance in-line with Public Health England recommendations. Approve the following dosing regimen (A, B, and C): A) Maximum single dose: 84 mg intranasally; AND B) Induction phase (Weeks 1 to 4): twice weekly dosing; AND C) Maintenance phase (Weeks 5 and after): up to once weekly dosing. to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. Sulpiride: Clozapine and other antipsychotics: monitoring blood concentrations for toxicity [MHRA/CHM advice]. Amisulpride: Clozapine and other antipsychotics: monitoring blood concentrations for toxicity [MHRA/CHM advice]. Dr. Prashad understands the importance of creating unique treatment plans for each patient including combining ketamine with oral medications or Brainsway’s deep TMS in order to maximize results. Benefit–risk assessment is an integral part of the regulatory approval process and is necessary throughout the lifecycle of a drug. Ketamine infusion has not been approved by the FDA to treat depression. © The Royal Pharmaceutical Society 2021. metastatic hormone-naïve prostate cancer (mHNPC) Approved Approved sNDA … • Erythromycin: caution required due to cardiac risks (QT interval prolongation); drug interaction with rivaroxaban [MHRA/CHM advice]. The FDA, has approved a new medication for the treatment of Depression, Spravato (Esketamine) which is an isomer of the drug Ketamine. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar 2021) and others. Date of Original Approval: February 7, 2012. Bedaquiline in combination regimen for multiple-drug resistant pulmonary tuberculosis [AWMSG guidance]. • Venetoclax with obinutuzumab for untreated chronic lymphocytic leukaemia [NICE guidance]. Methotrexate once-weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing [MHRA/CHM advice]. This update contains 29 significant changes, 5 dose changes, 2 new monographs and 1 new preparation. Osimertinib for treating EGFR T790M mutation-positive advanced non-small-cell lung cancer [NICE guidance]. Date of Original Approval: January 31, 2012. • Lenvatinib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice]. who are age 75 years or older, or who have comorbidities that preclude use Sklice (ivermectin) Lotion is a pediculicide indicated for the topical treatment of head lice infestations in patients 6 months of age and older. • Trabectedin (Yondelis®) for the treatment of adult patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents [SMC guidance]. Date of Original Approval: March 10, 2011. the treatment of adults and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA). New Formulation Approved: October 9, 2020 Date of Original Approval: December 19, 2014. • Romosozumab (Evenity®) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture [SMC guidance]. Enhertu (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting; and adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. Date of Original Approval: October 28, 2008. SPRAVATO ® (esketamine) CIII Nasal Spray is indicated, in conjunction with an oral antidepressant, for the treatment of: . 1 , 2 Assessing and weighing the potential benefits and risks of an investigational drug is critical for decision making by regulators, clinicians, and patients. Acute Suicidal Ideation or Behavior. Labeling Revision Approved: December 21, 2020 • Nintedanib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice]. Esketamine nasal spray (JNJ-54135419) is in clinical development for adults with MDD with imminent risk of suicide, in phase III clinical trials (ASPIRE I; NCT03039192 and ASPIRE II; NCT03097133).3,4 The proposed esketamine nasal spray dosing regimen for this indication is 84mg (3 devices of 28 mg each) two times per week for four weeks.c Monitor patients for at least two hours after administration. Ultomiris (ravulizumab-cwvz) is a long-acting C5 complement inhibitor for: New Indication Approved: October 2, 2020 Spravato contains the drug esketamine. nasal polyps in adult patients 18 years of age and older. • Darolutamide (Nubeqa®) for the treatment of adult men with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease [SMC guidance]. Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma (BCC), and non-small cell lung cancer (NSCLC). New Indication Approved: November 5, 2020 Vedolizumab for the treatment of adults with moderately to severely active Crohn’s disease [SMC guidance]. for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Brentuximab vedotin in combination for untreated systemic anaplastic large cell lymphoma [NICE guidance]. for the treatment of adult patients with unresectable, Stage III, in combination with etoposide and either carboplatin or cisplatin, as first-line treatment of adult patients with extensive-stage. Wakix (pitolisant) is a histamine-3 (H₃) receptor antagonist/inverse agonist for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy. There has been much interest in the role of ketamine as a … • Sarclisa® [isatuximab]. • Fluorouracil: Fluorouracil (i.v. Background: Ketamine, administered in subanesthetic doses, is an effective off-label treatment for severe and even treatment-refractory depression; however, despite dozens of studies across nearly 2 decades of research, there is no definitive guidance on matters related to core practice issues. Hetlioz (tasimelteon) is a melatonin receptor agonist for the treatment of Non-24-Hour Disorder in adults, and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older. Yescarta (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy (CAR T-cell therapy) indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B cell lymphoma, and DLBCL arising from follicular lymphoma. At Janssen CarePath, we get that there's a lot that goes into managing billing and reimbursement, so we've put together information you may need for DARZALEX FASPRO™.. Ocrevus (ocrelizumab) is a humanized monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin and axonal nerve cell damage. Available for Android and iOS devices. Learn about side effects, warnings, dosage, and more. Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). Benlysta (belimumab) is B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE), and adult patients with active lupus nephritis. Date of Original Approval: June 20, 2003, New Indication Approved: December 1, 2020 Date of Original Approval: May 1, 2020. ... Esketamine is the S-enantiomer of racemic ketamine. This update contains 25 significant changes, 2 dose changes, 4 new monographs, 4 deleted monographs and 1 deleted preparation. Dovato (dolutegravir and lamivudine) is a combination of the integrase strand transfer inhibitor dolutegravir (Tivicay) and the nucleoside analogue reverse transcriptase inhibitor lamivudine (Epivir) used for the treatment of HIV-1 infection in adults. Olanzapine: Clozapine and other antipsychotics: monitoring blood concentrations for toxicity [MHRA/CHM advice]. Pembrolizumab with axitinib for first-line treatment of advanced renal cell carcinoma [SMC guidance]. The acute antisuicidal effects of single-dose intravenous ketamine and intranasal esketamine in individuals with major depression and bipolar disorders: A systematic review and meta-analysis. Monitor patients for at least two hours after administration. Humira (adalimumab) is a recombinant human IgGl monoclonal antibody specific for human tumor necrosis factor (TNF) indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, psoriasis, juvenile idiopathic arthritis, ulcerative colitis, hidradenitis suppurativa, and certain types of uveitis. Date of Original Approval: October 21, 2019. New Indication Approved: December 1, 2020 • Kliovance® (estradiol with norethisterone) [update to dosing]. Date of Original Approval: September 28, 2018. Ketamine’s development was driven by the observation that phencyclidine was a useful anesthetic agent but caused serious neuropsychiatric adverse events (eg, delirium, psychosis, dissociative … SUMMARY For most drugs, the selection of a product’s dosing regimen is based upon efficacy, safety and pharmacokinetics (plasma half-life) 1.In the esketamine (ESK) program for treatment-resistant depression (TRD), the dosing regimen also accounted for the pharmacodynamic properties of ESK nasal spray, namely durability of the antidepressant effect. Date of Original Approval: September 4, 2014, New Indication Approved: October 13, 2020 Significant Changes: • Andexanet alfa (Ondexxya®): avoid use of andexanet prior to heparinisation [MHRA/CHM advice]. 16 When a multiple-dose regimen of 500mg three times a day administered intravenously, steady-state concentrations were achieved within about 3 days and peak concentration was measured at 26 mg/L. Polatuzumab vedotin with rituximab and bendamustine for the treatment of relapsed or refractory diffuse large B-cell lymphoma [NICE and SMC guidance]. Influenza vaccine [update to dosing for immunisation]. Clozapine: Clozapine and other antipsychotics: monitoring blood concentrations for toxicity [MHRA/CHM advice]. Treosulfan with fludarabine for malignant disease before allogeneic stem cell transplant [NICE guidance]. • Patiromer calcium (Veltassa®) for the treatment of hyperkalaemia in adults [SMC guidance]. Venclexta (venetoclax) is an oral B-cell lymphoma-2 (BCL-2) inhibitor indicated: Labeling Revision Approved: October 14, 2020 Date of Original Approval: October 18, 2017. Xeomin (incobotulinumtoxinA) is a botulinum toxin type A for the treatment of cervical dystonia, blepharospasm, glabellar lines, upper limb spasticity, and excessive drooling. FDA Approves Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the Treatment of Asthma, FDA Approves Additional Doses of Trulicity (dulaglutide) for the Treatment of Type 2 Diabetes, FDA Approves New Kyprolis (carfilzomib) Combination Regimen with Darzalex (daratumumab) and Dexamethasone in Both Once- And Twice-Weekly Dosing Regimens, ViiV Healthcare Announces FDA Approval of an Expanded Indication for Dovato (dolutegravir/lamivudine), a Complete Two-Drug Regimen for Virologically Suppressed Adults with HIV-1, FDA Approves Epidiolex (cannabidiol) Oral Solution to Treat Seizures Associated with Tuberous Sclerosis Complex, FDA Approves Spravato (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior, FDA Approves Genentech’s Tecentriq plus Cotellic and Zelboraf for People With Advanced Melanoma. Date of Original Approval: April 8, 2019. Date of Original Approval: December 14, 2012, New Indication Approved: December 18, 2020 For patients receiving 300 mg/day to 400 mg/day of levodopa as immediate-release carbidopa-levodopa, the suggested starting regimen of Sinemet CR is carbidopa 50 mg/levodopa 200 mg twice daily. Oseltamivir [update to dosing for treatment and prevention of influenza]. as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes. • Doxorubicin hydrochloride: Liposomal and lipid-complex formulations: name change to reduce medication errors [MHRA/CHM advice]. Haemophilus influenzae type B conjugate vaccine: updated guidance in-line with Public Health England recommendations. Date of Original Approval: December 22, 2014, New Indication Approved: September 30, 2020 Short-term efficacy was established in 2 placebo-controlled trials (8 week duration). Deleted Preparations: Climagest® 1 mg [estradiol with norethisterone]; Climagest® 2 mg [estradiol with norethisterone]; Climesse® [estradiol with norethisterone]. DARZALEX (Daratumumab) - ALCYONE. Immunoglobulins: updated guidance on the use of varicella-zoster immunoglobulin in-line with Public Health England recommendations. The BNF is the only drug formulary in the world that is both independent, and has rigorous, accredited content creation processes. The mechanism by which esketamine exerts its antidepressant effect is unknown. This update contains 20 significant changes and 2 new monographs. to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Date of Original Approval: October 24, 2018. • Cytarabine: Liposomal and lipid-complex formulations: name change to reduce medication errors [MHRA/CHM advice]. Select one or more newsletters to continue. • Ofloxacin [update to dosing for complicated skin and soft-tissue infections]. Journal of Psychiatric Research, Vol. ZYTIGA (abiraterone acetate) - LATITUDE. New Indication Approved: December 20, 2020 Individualize regimen based upon response and tolerability. ), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe and fatal toxicity [MHRA/CHM advice]. Date of Original Approval: July 7, 2015. The peak activity is noted after 2 to 3 hours. Patient Population Altered: February 24, 2021 The lowest GoodRx price for the most common version of generic Meclizine Non-Prescription is around $2.89, 42% off the average retail price of $5.04. Cariprazine for the treatment of schizophrenia [AWMSG guidance]. • Quofenix® [delafloxacin]. See also: New Drug Approvals, New Drug Applications, Recent Additions to Drugs.com. Xeljanz (tofacitinib) is an oral Janus kinase (JAK) inhibitor used for the treatment of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis. The duration of action of one single dose is 6 to 12 hours in a dose dependent manner. While use is not limited to this setting, the efficacy of Brilinta was established in a population with type 2 diabetes mellitus (T2DM). Neratinib for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer [SMC guidance]. Doravirine in combination with other antiretroviral drugs for the treatment of adults infected with HIV-1 [AWMSG guidance]. • Pembrolizumab for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma [NICE guidance]. T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL. • Interactions: drugs that cause myelosuppression: pharmacodynamic effects drug group revalidated and updated. However, illicit use of the medication comes with risks, and the DEA has been following its distribution closely. Prior to dosing with Spravato blood pressure should be assessed. Clarity’s Diagnosis and Treatment Guidance, Dale and Appelbe’s Pharmacy and Medicines Law, Drug Administration via Enteral Feeding Tubes, http://www.medicinescomplete.com/mc/bnf/current/PHP107699-changes.htm, https://www.medicinescomplete.com/#/content/bnf/PHP107699. New Dosage Regimen: August 20, 2020 Lamivudine with tenofovir disoproxil and doravirine for the treatment of adults infected with HIV-1 [AWMSG guidance]. Date of Original Approval: March 28, 2017. Cannabidiol with clobazam for therapy of seizures associated with Lennox-Gastaut syndrome [SMC guidance]. Xofluza (baloxavir marboxil) is a polymerase acidic (PA) endonuclease inhibitor for the treatment of influenza, and for the post-exposure prophylaxis of influenza in people 12 years of age and older. Olanzapine embonate: Clozapine and other antipsychotics: monitoring blood concentrations for toxicity [MHRA/CHM advice]. Corporate Medical Policy Esketamine (Spravato™) Nasal Spray File Name: esketamine_spravato_nasal_spray Origination: 5/2019 Last CAP Review: n/a Next CAP Review: 6/2019 Last Review: 5/2019 Description of Procedure or Service Esketamine (Spravato ™ ) nasal spray is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist that is indicated, in conjunction with an … • Pirfenidone (Esbriet®): risk of serious liver injury; updated advice on liver function testing [MHRA/CHM advice]. Kyprolis (carfilzomib) is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma. Dose Changes: • Cefixime [update to dosing for uncomplicated gonorrhoea]. • Ofloxacin [update to dosing for lower respiratory-tract infections]. • Avatrombopag (Doptelet®) for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure [SMC guidance]. Participants from each group will receive different dosing sequences, consider as a single dose, corresponding to low, medium, high Esketamine dose or placebo. • Amphotericin: name change to amphotericin B. New Indication Approved: February 1, 2021 The present invention is directed to methods and dosing regimens for the treatment of depression (preferably, treatment resistant depression), for the treatment of depression in a suicidal patient, and/or for the treatment and/or prevention of suicidality (e.g. Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for use in the treatment of urothelial carcinoma, non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), small cell lung cancer (SCLC), heptatocellular carcinoma and melanoma. Opioids: risk of dependence and addiction [MHRA/CHM advice] (advice in alfentanil, buprenorphine, co-codamol, codeine phosphate, co-phenotrope, diamorphine hydrochloride, dihydrocodeine tartrate, fentanyl, hydromorphone hydrochloride, kaolin with morphine, meptazinol, methadone hydrochloride, morphine, oxycodone hydrochloride, pentazocine, pethidine hydrochloride, remifentanil, tapentadol, tramadol hydrochloride; see example in morphine).

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