All antiretroviral combinations are screened against the most recent DHHS guidelines for the use antiretroviral therapy in adolescents and adults https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical- guidelines-adult-and-adolescent-arv/whats-new-guidelines for high dosage and non-recommended组合。在裁决时可能会拒绝不符合这些准则的方案。
全部处方信息:内容*警告:ESA增加了死亡的风险,心肌梗塞,中风,静脉血栓栓塞,血管通道的血栓形成,肿瘤的进展或复发或复发1.1 1.1 1.1由于慢性肾脏疾病而导致的慢性肾脏疾病1.2因肿瘤患者而导致的1.2脑血症1. 3肌炎1.3 ANEMIA 1.3 ANEMIA 1.3 ANEMIA 1.3 ANEMIA 1.3 ANEMIA 1.3 ANEMIA 1.3 ANEMIA 1.3 ANEMIA 1.3,33例3的病毒疗法。 Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery 1.5 Limitations of Use 2 DOSAGE AND ADMINISTRATION 2.1 Important Dosing Information 2.2 Patients with Chronic Kidney Disease 2.3 Zidovudine-treated Patients with HIV Infection 2.4 Patients on Cancer Chemotherapy 2.5 Surgery Patients 2.6 Preparation and Administration 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS
第1节定义..............................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................第1第2节。IMMUNIZATION REQUIRED ................................................................................第1页第3节。EXCEPTIONS .............................................................................................................第2页第4节。免疫证书;免疫力的证据....................................第3页第5节。IMMUNIZATION DOSAGE .....................................................................................第3页第6节。EXCLUSION FROM SCHOOL ................................................................................第4页第7节。RECORDS AND RECORD KEEPING ....................................................................第5页第8节。REQUIRED REPORTS .............................................................................................Page 6 STATUTORY AUTHORITY ...........................................................................................................第7页
6 ADVERSE REACTIONS WARNING: HEPATOTOXICITY, 6.1 Clinical Trials Experience CARDIOVASCULAR RISK, AND 7 DRUG INTERACTIONS GASTROINTESTINAL RISK 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 1 INDICATIONS AND USAGE 8.2 Lactation 2 DOSAGE AND ADMINISTRATION 8.3 Females and Males of Reproductive Potential 3 DOSAGE FORMS AND STRENGTHS 8.4 Pediatric Use 4 CONTRAINDICATIONS 8.5 Geriatric Use 5 WARNINGS AND PRECAUTIONS 8.6 Use in Renal Disease 5.1 Hepatotoxicity 8.7 Use in Hepatic Disease 5.2 Cardiovascular Thrombotic Events 10 OVERDOSAGE 5.3 Gastrointestinal Bleeding, Ulceration, and 11 DESCRIPTION Perforation 12 CLINICAL PHARMACOLOGY 5.4 Hypertension 12.1 Mechanism of Action 5.5 Heart Failure and Edema 12.2 Pharmacodynamics 5.6 Renal Toxicity and Hyperkalemia 12.3药代动力学5.7过敏反应和其他超敏反应13非临床毒理学反应13.1癌变,诱变和生育能力损害5.8与阿司匹林的哮喘加剧14临床研究敏感性敏感性敏感性16提供/储存和处理方式。
类别申请信息申请类型NDA申请编号214662优先级或标准优先级提交日期1/29/2021收到的日期1/29/2021 PDUFA目标日期9/29/2021 2021分司/办公室/办公室肝病学和营养(DHN)审查日期(DHN)审查日期9/23/20221223/20221 ARMAT ARMITATIRE(MARRAT) Livmarli药理学类肠胃胆酸转运蛋白(IBAT)抑制剂代码名称胆固性肝疾病(即,原发性胆道肝硬化和原发性硬化性胆管炎)(7060106)(7060106)Dosage form(s)/formulation(s) Liquid formulation Dosing regimen 380 mcg/kg/day Applicant proposed indication(s)/ population(s) Treatment of cholestatic pruritus in patients with Alagille syndrome 1 year of age and older Proposed SNOMED indication Alagille syndrome (code 31742004 arteriohepatic dysplasia disorder) Regulatory action Approval Approved dosage (如果适用)请参见上述剂量方案批准的指示(如果适用)(如果适用),请参见上述指示(s)/人群批准的指示术语(如果适用)
完整处方信息:目录 * 1 适应症和用法 1.1 特应性皮炎 1.2 哮喘 1.3 伴有鼻息肉的慢性鼻窦炎 1.4 嗜酸细胞性食管炎 1.5 结节性痒疹 1.6 慢性阻塞性肺病 2 剂量和给药 2.1 重要给药说明 2.2 治疗前接种疫苗 2.3 特应性皮炎的推荐剂量 2.4 哮喘的推荐剂量 2.5 伴有鼻息肉的慢性鼻窦炎的推荐剂量 2.6 嗜酸细胞性食管炎的推荐剂量 2.7 结节性痒疹的推荐剂量 2.8 慢性阻塞性肺病的推荐剂量 2.9 漏服剂量 2.10 使用准备 3剂型和强度 4 禁忌症 5 警告和注意事项 5.1 过敏症 5.2 结膜炎和角膜炎 5.3 嗜酸性粒细胞增多症 5.4 哮喘或慢性阻塞性肺病的急性症状或急性恶化性疾病 5.5 皮质类固醇剂量突然减少的相关风险 5.6 合并哮喘的患者 5.7 关节痛
完整处方信息:内容* 1符号和用法1.1 BRCA被释放(G BRCA M)HER2阴性局部晚期或转移性乳腺癌1.2 HRR基因 - 基因 - 基因氧化MCRPC 2剂量2剂量2 2.1患者选择2.1患者选择2.1 2.2建议GBRCA M Her2nopative局部先进或转移的剂量2.2推荐的剂量2.3 2.4给药2.5不良反应的剂量修饰2.6肾脏损伤患者的建议剂量2.7 p-糖蛋白抑制剂的剂量改良剂3剂量和优势3剂量和优势4禁忌措施5警告和预防措施5.1骨髓疾病综合征/急性肌动型5.2 myeloid liosia 5.2 myeloid liosia 5.2 myeloid liosia 5.2 myeloid liosia 5.2 3.3 6.1临床试验经历7种药物相互作用7.1其他药物对TALZENNA的影响
1.2.1.1 Capsules, hard shell 1.2.1.2 Capsules, soft shell 1.2.1.3 Chewing gums 1.2.1.4 Impregnated matrices 1.2.1.5 Liquids for external use 1.2.1.6 Liquids for internal use 1.2.1.7 Medicinal gases 1.2.1.8 Other solid dosage forms 1.2.1.9 Pressurised preparations 1.2.1.10 Radionuclide generators 1.2.1.11半固体1.2.1.12栓剂1.2.1.13片1.2.1.14透皮贴剂1.2.1.15仪内装置1.2.1.16兽医预示1.2.1.1.17其他
全部处方信息:内容 *警告:严重感染的风险1 1.1 1.1类风湿关节炎(RA)1.2多肌痛性风湿病(PMR)1.3多关节少年少年少年性特发性关节炎(PJIA)之前2.1剂量2.1 rhemation 2.1 rhritis 2.2.2 Rhyum 2. Rhyum 2. 2. 2 Rhyumation Pression deS.2 rhrium deSATIED DOSIATED DESIATED DESIATIED DESIATION DESIATION DESITAID PRHAIMATIED DOSIATIED PRHAIMATIEN DESIATIED DESIATION DESIATIED DESIATIS 2.2多肌痛风湿性2.4建议用于多节幼年特发性关节炎2.5制备和给药说明2.6剂量修改细胞质的剂量改良,肝脏异常酶,异常异常,或感染3剂量和强度3剂型3剂量3剂量5次疾病5 pernefitions 5 Aperniontions 5.2 Aperniptions 5.2 Aperniptions 5.2 25.2穿孔5.4免疫抑制5.5超敏反应
Each vaccine-specific EUA Fact Sheet for Recipients will provide the following information: • Basic information on COVID-19, symptoms, and what to discuss with a healthcare provider before vaccination • Who should and should not receive the vaccine • That recipients have the choice to receive the vaccine • Dosage and vaccine series information • Risks and benefits of the vaccine, including common side effects • Information on reporting side effects to VAERS • An explanation of EUA是什么以及为什么发出的•任何可预防COVID-19的批准的替代方案•其他资源