Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery: a Randomized Controlled Trial

The goal of this study is to compare 2 medications that are commonly used to prevent excess uterine bleeding (postpartum hemorrhage, or PPH) following cesarean delivery (CD), oxytocin and carbetocin. Most of the trials evaluating the preventative role of oxytocin and carbetocin after CD have focused on patient with low-risk of PPH.
This trial will focus on patients that are at increased risk of PPH, with risk factors such as: multiple gestation (twins, or more multiples), large baby, polyhydramnios (excess amniotic fluid), history of PPH, body mass index greater than 40, diabetes mellitus, hypertension, and placenta previa.
The investigators hypothesize that carbetocin would be more effective than an oxytocin regimen in reducing the risk of PPH in patients undergoing CD with any of the biological high-risk factors.

开始日期2024-11-01

申办/合作机构

Samuel Lunenfeld Research Institute

NCT06692621

/ RecruitingN/AIIT

Effects of Carbetocin and Oxytocin Used in Cesarean Sections on Postoperative Pain

The aim of this observational study is to compare postoperative analgesic consumption in patients who received peroperative carbetocin or oxytocin. The main question it aims to answer is:
. Does peroperative carbetocin use reduce postoperative analgesic consumption compared to oxytocin?
Patients who receive routine uterotonic agents in caesarean section surgeries will be divided into two groups and their postoperative 24-hour analgesic consumption will be compared.

开始日期2024-10-04

申办/合作机构

Ankara Bilkent City Hospital

TCTR20241030008

/ CompletedN/AIIT

Comparing the effectiveness of Carbetocin and Oxytocin in preventing postpartum hemorrhage in preeclampsia

开始日期2024-10-01

申办/合作机构-

100 项与卡贝缩宫素相关的临床结果

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100 项与卡贝缩宫素相关的转化医学

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100 项与卡贝缩宫素相关的专利（医药）

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项与卡贝缩宫素相关的文献（医药）

2025-02-01·European Journal of Obstetrics & Gynecology and Reproductive Biology

Shock index reference ranges in the first 48 h postpartum following elective cesarean delivery: A prospective cohort study

Article

作者: Kayikci, Umutcan ; Sinci, Umut ; Yulek, Zeynep ; Cagan, Murat ; Deren, Ozgur ; Bayrak, Ayse Cigdem ; Fadiloglu, Erdem

PURPOSETo determine the reference values for the shock index (SI) in postpartum patients undergoing elective cesarean delivery with regional anesthesia.METHODSThis prospective study was conducted at our tertiary center between August 1, 2023, and March 1, 2024. We calculated the reference values for the SI within the first 48 h postpartum for patients who underwent elective cesarean delivery after the 34th week of gestation. We excluded cases of vaginal delivery, post-term delivery (≥42 weeks of gestation), multiple pregnancies, stillbirths, fetal abnormalities, maternal cardiac disease, anemia, untreated hypo- or hyperthyroidism, and any hypertensive disorders diagnosed before or during pregnancy. Data collection, measurement of vital signs, and the administration of fluids pre-, intra-, and post-operatively, as well as the use and dosing of uterotonic agents for the prevention of postpartum hemorrhage (PPH), were standardized for all patients.RESULTSOur final analysis included 311 patients, with a mean SI value of approximately 0.7 (0.67-0.77) for all measurement performed within the first 48 h of the postpartum period. Further analyses revealed that the 90th and 95th percentiles of SI were around 0.9 throughout the study period. Additionally, SI reference values analyzed at different time points were consistent. Our analysis demonstrated that SI values were not influenced by the presence of a previous caesarean section, the administration of oxytocin or carbetocin, or parity in this particular cohort. Our analyses of vital signs also indicated that the 95th percentile of heart rate (HR) ranged from 96 to 100 bpm.DISCUSSIONAn SI value of 0.9 represents the 95th percentile of SI values throughout the first 48 h of the postpartum period. Any greater value should be evaluated carefully for potential adverse outcomes.

2025-01-15·The Journal of Maternal-Fetal & Neonatal Medicine4区 · 医学

Effect of heat stable carbetocin vs oxytocin for preventing postpartum haemorrhage on post delivery hemoglobin–a randomized controlled trial.

4区 · 医学

Article

作者: Somannavar, Manjunath S. ; Vernekar, Sunil S. ; Pujar, Yeshita V. ; Carvalho, José Ferreira D. E. ; Goudar, Swati S. ; Gulmezoglu, Ahmet Metin ; Goudar, Shivaprasad S. ; Widmer, Mariana ; Metgud, Mrityunjay ; Piaggio, Gilda ; Revankar, Amit ; Althabe, Fernando

OBJECTIVETo compare the effect of heat-stable carbetocin 100 μg IM versus oxytocin 10 IU IM on post-delivery hemoglobin level.SETTINGHospital based study in Southern India.POPULATIONWomen delivering vaginally who were enrolled in the WHO CHAMPION trial in a single facility in India. WHO CHAMPION Trial was a randomized, double-blind, noninferiority trial comparing intramuscular injections of heat-stable carbetocin with oxytocin administered immediately after vaginal birth in women across 23 sites in 10 countries.METHODSThis was a nested randomized controlled trial designed to compare the effect of heat-stable carbetocin 100 μg IM versus oxytocin 10 IU IM, administered within one minute of vaginal delivery of the baby for prevention of postpartum hemorrhage, on post-delivery 48-72 h hemoglobin level, adjusted for pre-delivery hemoglobin level. 1,799 women from one hospital in India participated in this study.RESULTSPre-delivery hemoglobin and postpartum blood loss were not significantly different between carbetocin and oxytocin. Post-delivery hemoglobin, unadjusted or adjusted for pre-delivery hemoglobin, was slightly lower for carbetocin (10.09 g/dL) compared to oxytocin (10.21) (p value of 0.0432). The drop in hemoglobin was slightly higher for carbetocin, although the difference was very small (1.2 g/dL for carbetocin, 1.1 g/dL for oxytocin) (p value of .0786). The proportion of participants with a drop in hemoglobin of 2 g/dL or more, adjusted for pre-delivery hemoglobin, was higher for carbetocin (RR = 1.29, 95% CI 1.02-1.63). From the regression coefficients it can be derived that post-delivery hemoglobin, adjusted for pre-delivery hemoglobin, decreases on average 0.12 g/dL for each dL of blood lost, for the two treatments combined.CONCLUSIONThe present ancillary study showed that intramuscular administration of 100 µg of heat stable carbetocin can result in a slightly lower post-delivery hemoglobin, slightly higher drop and higher percentage of women having a drop of 2 g/dL or larger, compared to 10 IU of oxytocin.

2025-01-15·The Journal of Maternal-Fetal & Neonatal Medicine4区 · 医学

Carbetocin for the prevention of post-partum hemorrhage after vaginal birth: a real-world application

4区 · 医学

Article

作者: Baud, David ; Desseauve, David ; Sichitiu, Joanna

OBJECTIVETo compare maternal outcomes using Carbetocin versus Oxytocin for the active management of the third stage of labor, given a temporary national shortage of Oxytocin.METHODSWe conducted a retrospective observational study on a cohort of 866 women with vaginal deliveries at our center, >36 weeks of gestation, between November 2018 and March 2019. During the shortage period, each woman received a single slow intravenous injection of Carbetocin 100 µg at delivery of the anterior shoulder, rather than Oxytocin 5 UI, as postpartum hemorrhage prophylaxis. 146 (16.9%) patients received Carbetocin versus 720 (83.1%) receiving Oxytocin. The outcomes were rates of postpartum hemorrhage, severe postpartum hemorrhage, and placental retention.RESULTSIncidence rates of placental retention and postpartum hemorrhage were 4.9% and 9.4% respectively. Placenta retention was significantly more likely following Carbetocin administration (adjusted odds ratio 2.5; 95% confidence interval 1.2-5.0). Postpartum hemorrhage rates were not significantly different (adjusted odds ratio 1.1; 95% confidence interval 0.6-2.1), as were severe postpartum hemorrhage rates (adjusted odds ratio 0.7; 95% confidence interval 0.2-2.2).CONCLUSIONCarbetocin is as effective as Oxytocin for postpartum hemorrhage prevention. However, we would reserve it for use after placental delivery due to the increased retention rates.

项与卡贝缩宫素相关的新闻（医药）

2025-01-14

·Business Wire

Acadia Pharmaceuticals Provides Business and Pipeline Updates at 43rd Annual J.P. Morgan Healthcare Conference

SAN DIEGO--( BUSINESS WIRE )--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced multiple business updates and progress on the Company's CNS and rare disease drug candidates, which will be discussed today during a presentation by Catherine Owen Adams, Chief Executive Officer, at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA. “ 2025 is shaping up to be an exciting year as we build on the success of our two growing brands, NUPLAZID and DAYBUE, which together are projected to generate more than $1 billion in net sales this year,” said Catherine Owen Adams, Chief Executive Officer. “ In addition to growing our strong commercial franchises, we are laying the foundation for future growth through global expansion and pipeline advancement. Today, we announced our submission of a marketing authorization application for DAYBUE with the European Medicines Agency and anticipate beginning Managed Access Program–related sales in Europe as early as the second quarter. We are also pleased to share updates on our R&D pipeline—both today and at our first R&D Day in mid-2025—as our lead programs near data readouts. By expanding our reach beyond the U.S. and continuing to advance our pipeline, we believe Acadia is poised for sustained top-line growth and increasing positive cash flow.” Key 2025-2026 Milestones: Announced today that the marketing authorization application for DAYBUE ™ has been submitted to the European Medicines Agency (EMA) with expected approval in the first quarter of 2026. Initiation of Managed Access Programs in Europe in the second quarter of 2025, potentially resulting in the Company’s first revenues from outside the U.S. Enrollment of the last patient in the COMPASS PWS Phase 3 study of ACP-101 in Prader-Willi Syndrome anticipated in the fourth quarter of 2025, followed by top-line results announcement in the first half of 2026. Enrollment of the last patient in the RADIANT Phase 2 study of ACP-204 in Alzheimer’s disease psychosis expected in the first quarter of 2026, followed by top-line results announcement in mid-2026. Initiation of a Phase 2 study of ACP-204 for a second indication in Lewy Body Dementia in the third quarter of 2025. The Company will host its first ever R&D Day in mid-2025. Annual net sales for the full-year 2025 expected to exceed $1 billion for the first time in Company history. Today’s presentation will take place at 9:00 a.m. Pacific Time / 12:00 p.m. Eastern Time. A live webcast of the presentation will be accessible on the Company’s website, Acadia.com, under the investors section and an archived recording will be available on the website for approximately one month following the presentation. About Acadia Pharmaceuticals Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis and multiple other programs targeting neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at Acadia.com and follow us on LinkedIn and X . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact and can be identified by terms such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential,” “continue” and similar expressions (including the negative thereof) intended to identify forward-looking statements. Forward-looking statements contained in this press release, include, but are not limited to, statements about: (i) our business strategy, objectives and opportunities, including support for and innovations in our pipeline assets and business development opportunities, and potential for enhanced shareholder value; (ii) plans for, including timing, development and progress of commercialization, and expected regulatory timelines for trofinetide in the EU; (iii) plans for our pipeline, including the timing and conduct of our clinical trials, anticipated enrollment milestones and the timing and results of data from our clinical trials; and (iv) our estimates regarding our future financial performance, profitability and capital requirements, including our full year 2024 financial guidance and potential achievement of our milestone of annualized net sales in 2025. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. Such risks, uncertainties and other factors include, but are not limited to: our dependency on the continued successful commercialization of NUPLAZID ® and DAYBUE and our ability to maintain or increase sales of NUPLAZID or DAYBUE; our plans to commercialize DAYBUE outside the U.S., including in Canada; the costs of our commercialization plans and development programs, and the financial impact or revenues from any commercialization we undertake; our ability to obtain necessary regulatory approvals for our product candidates and, if and when approved, market acceptance of our products; the risks associated with clinical trials and their outcomes, including risks of unsuccessful enrollment and negative or inconsistent results; our dependence on third-party collaborators, clinical research organizations, manufacturers, suppliers and distributors; the impact of competitive products and therapies; our ability to generate or obtain the necessary capital to fund our operations; our ability to grow, equip and train our specialized sales forces; our ability to manage the growth and complexity of our organization; our ability to maintain, protect and enhance our intellectual property; and our ability to continue to stay in compliance with applicable laws and regulations. Given the risks and uncertainties, you should not place undue reliance on these forward-looking statements. For a discussion of these and other risks, uncertainties and other factors that may cause our actual results, performance or achievements to differ, please refer to our quarterly report on Form 10-Q quarter ended September 30, 2024, filed with the SEC on November 7, 2024, available at www.sec.gov . The forward-looking statements contained herein are made as of the date hereof, and we undertake no obligation to update them after this date, except as required by law.

临床3期上市批准临床2期

2024-12-17

·BioPharmaDive

Maternal mortality trends are dire — and reversing them remain an uphill battle

Maternal mortality in the U.S. has been on the rise, with the rate per 100,000 live births more than doubling from the first decade of the 2000s to the second.Health equity remains a major piece of the puzzle. As of 2022, Black women were more than twice as likely to die from a pregnancy-related condition than women of other racial backgrounds. This highlights shortcomings in access to care, but also points to the general lack of research in the field, said A. Metin Glmezoglu, executive director at the nonprofit Concept Foundation, which leads a project called Accelerating Innovation for Mothers.There have been very few new medicines being registered for these pregnancy conditions in the last 30 to 40 years, Glmezoglu said. If you compare this to innovations in other areas like chronic diseases, it's really tiny in terms of the number of solutions we have.The slow pace of innovation can be traced back to two major mid-20th century tragedies related to prescription drugs the nausea medicine thalidomide for pregnant women led to severe birth defects in thousands of children in the 1950s and 1960s and, not long after that, the hormone diethylstilbestrol was found to cause cancer in women who had been exposed to it in utero.These developments chilled drug research involving pregnant women. But in a twist of fate, what was meant to protect women and their children made it harder to find new drugs for them, Glmezoglu said, driving up mortality rates.These tragedies created this enormous fear and risk averseness in this area because those two drugs were not actually researched properly without a rigorous evaluation before, Glmezoglu said. That created this mindset that pregnant women are vulnerable and we have to protect the fetus, even if it means we have to withhold medication a woman might need.The research shortcomings are global, but they have a greater impact among women in low- and middle-income countries, where clinical research is less, Glmezoglu said.Other challenges include the limited time period of pregnancy, which makes drug testing more difficult. All of these combine for a perfect storm where nobody's investing in this field, he added.A gendered problemWhen women take part in clinical research and become pregnant, they are often taken out of that trial, Glmezoglu said, further thinning the data that becomes available.All of these differences tend to push evaluation to male bodies, male cell cultures and so on, which in the short term may be helpful because you can find solutions easier, but it doesn't help because you are not developing solutions for the other 50% of the population, Glmezoglu said.This was made clear during the COVID-19 pandemic, when vaccine trials excluded pregnant women, even though they were at higher risk of mortality and morbidity from the virus. That shifted the responsibility to healthcare providers and patients to decide whether to receive a shot.Gaining traction for a widespread push to study women's health issues more could partly hinge on winning political and public support.Inclusion of women and inclusion of pregnant and lactating women in trials has for many years been a secondary concern, Glmezoglu said. Any political process that does not support inclusivity and equality is likely to have an adverse effect on women's inclusion in research as a general concern.Mercks effortsJacquelyn Caglia, director of learning, communications and U.S. programs, Merck for MothersPermission granted by Merck for MothersOne success story came out of pharmaceutical giant Merck & Co. in 2018, which through its Merck for Mothers initiative studied the use of heat-stable carbetocin, finding it was not inferior to the standard of care oxytocin at preventing excessive bleeding after birth. The heat-stable nature of the new compound makes it easier to use in countries where refrigeration is difficult to come by.Merck for Mothers has been building evidence for maternal mortality trends since 2011 and providing women with education and health solutions in the U.S., India, Kenya and Nigeria. The initiative has reached more than 30 million women in that time, said Jacquelyn Caglia, director of learning, communications and U.S. programs at Merck for Mothers.Caglias vision is to see a healthcare system with a plan in place to treat mothers in the same way it treats newborns.What are our opportunities to think about mom and baby receiving care together? Our system across the U.S. is not quite set up that way, Caglia said. We have a very clear schedule for the types of care and visits and the timing of those visits that newborns need to have but what's our opportunity to think about mom and the care that they should be receiving alongside the newborn at those same points in time?Through programs like the Safer Childbirth Cities which supports community organizations in cities with high maternal mortality rates Merck for Mothers aims to meet mothers where they are, reducing geographic disparities that cause gaps in outcomes.We're still seeing in our national trends across the U.S. and globally, that most of the deaths, most of the complications, are preventable, which points us in the direction of where we need to intervene, Caglia said. There are continued patterns of differences based on race and ethnicity as well as based on geography ... and those disparities demand our attention. '

疫苗

2024-12-08

·药筛

武汉先路氟比洛芬滴眼液首仿获批，吗啉硝唑新增3家仿制获批 | 仿制药周报（12.2-12.08）

统计每周仿制药一致性评价申报、上市申请（12.2-12.08） 1、仿制药上市申请获批药品名称企业名称分类受理号阿戈美拉汀片深圳市泛谷药业股份有限公司;深圳信立泰药业股份有限公司4CYHS2302531阿戈美拉汀片杭州领业医药科技有限公司4CYHS2302278阿戈美拉汀片重庆华森制药股份有限公司4CYHS2301877阿帕他胺片齐鲁制药（海南）有限公司4CYHS2302520阿普米司特片常州制药厂有限公司4CYHS2301812阿普米司特片常州制药厂有限公司4CYHS2301811阿普米司特片常州制药厂有限公司4CYHS2301810阿普米司特片广东迈恒医药研发有限公司;广东隆赋药业股份有限公司4CYHS2301478阿普米司特片广东迈恒医药研发有限公司;广东隆赋药业股份有限公司4CYHS2301477阿普米司特片广东迈恒医药研发有限公司;广东隆赋药业股份有限公司4CYHS2301476阿奇霉素干混悬剂迪沙药业集团有限公司4CYHS2301207阿司匹林肠溶片仁合益康集团有限公司;河北仁合益康药业有限公司4CYHS2302409阿昔莫司胶囊浙江高跖医药科技股份有限公司;浙江赛默制药有限公司4CYHS2303120氨己烯酸口服溶液用散远大医药（中国）有限公司3CYHS2300027氨甲环酸注射液广州泽盛药业科技有限公司;山东辉成药业有限公司4CYHS2301435氨甲环酸注射液广州泽盛药业科技有限公司;山东辉成药业有限公司4CYHS2301434氨甲环酸注射液广州泽盛药业科技有限公司;山东辉成药业有限公司4CYHS2301436氨溴特罗口服溶液江西仁齐制药有限公司;湖南九典制药股份有限公司3CYHS2301066氨溴特罗口服溶液海南天盛保和生物科技有限公司;安徽永生堂药业有限责任公司3CYHS2300745氨溴特罗口服溶液南京卡文迪许生物工程技术有限公司;江苏云阳集团药业有限公司3CYHS2300568氨溴特罗口服溶液浙江康润制药有限公司3CYHS2300383氨溴特罗口服溶液浙江康润制药有限公司3CYHS2300382奥美沙坦酯氢氯噻嗪片宁波科尔康美诺华药业有限公司;宁波美诺华天康药业有限公司4CYHS2300248奥沙利铂注射液贵州阜康仁制药有限公司;哈尔滨医大药业股份有限公司3CYHS2300670巴氯芬口服溶液江苏天士力帝益药业有限公司;南京海纳制药有限公司3CYHS2301070苯磺酸氨氯地平片吉林敖东药业集团延吉股份有限公司4CYHS2301986比索洛尔氨氯地平片福建海西新药创制股份有限公司;广东安诺药业股份有限公司4CYHS2302208丙戊酸钠口服溶液安徽海斯美医药有限公司;扬州市三药制药有限公司4CYHS2301421玻璃酸钠滴眼液华熙生物科技股份有限公司;北京汇恩兰德制药有限公司4CYHS2301663布洛芬缓释胶囊南京华兴医药科技有限公司;湖北荆江源制药股份有限公司4CYHS2301450布洛芬混悬滴剂江苏万高药业股份有限公司4CYHS2302104醋酸维持液(含葡萄糖)石家庄四药有限公司3CYHS2301103醋酸维持液(含葡萄糖)石家庄四药有限公司3CYHS2301104达比加群酯胶囊Hetero Labs Limited5.2JYHS2000002达比加群酯胶囊Hetero Labs Limited5.2JYHS2000006达比加群酯胶囊Hetero Labs Limited5.2JYHS2000003达格列净二甲双胍缓释片南京正大天晴制药有限公司3CYHS2300498达格列净二甲双胍缓释片南京正大天晴制药有限公司3CYHS2300499达格列净片浙江华义制药有限公司4CYHS2301952达格列净片浙江华义制药有限公司4CYHS2301953达格列净片浙江华海药业股份有限公司4CYHS2300694达格列净片浙江华海药业股份有限公司4CYHS2300693地高辛注射液江苏联环药业股份有限公司3CYHS2301735地夸磷索钠滴眼液浙江尖峰药业有限公司4CYHS2302723地夸磷索钠滴眼液国药集团三益药业（芜湖）有限公司4CYHS2302234地诺孕素片博瑞制药（苏州）有限公司;浙江仙琚制药股份有限公司4CYHS2300580碘比醇注射液重庆圣华曦药业股份有限公司4CYHS2300167碘比醇注射液重庆圣华曦药业股份有限公司4CYHS2300166碘佛醇注射液成都倍特药业股份有限公司4CYHS2301601碘佛醇注射液成都倍特药业股份有限公司4CYHS2301602恩格列净片湖南迪诺制药股份有限公司4CYHS2302022二甲双胍恩格列净片(Ⅰ)杭州云柏医药科技有限公司;浙江赛默制药有限公司4CYHS2300814二甲双胍恩格列净片(Ⅴ)杭州云柏医药科技有限公司;浙江赛默制药有限公司4CYHS2300815二甲双胍维格列汀片(Ⅱ)宁波美诺华天康药业有限公司4CYHS2302306二羟丙茶碱注射液森淼（山东）药业有限公司;湖北津药药业股份有限公司3CYHS2301556二羟丙茶碱注射液浙江和泽医药科技股份有限公司;浙江康恩贝制药股份有限公司3CYHS2301480二羟丙茶碱注射液安徽长江药业有限公司;安徽恒星制药有限公司3CYHS2300942法莫替丁注射液南京康发生物科技有限公司;马鞍山丰原制药有限公司3CYHS2301437非诺贝特酸胆碱缓释胶囊鲁南贝特制药有限公司;吉林天衡英睿制药有限公司4CYHS2301088非诺贝特酸胆碱缓释胶囊鲁南贝特制药有限公司;吉林天衡英睿制药有限公司4CYHS2301087呋塞米注射液武汉久安药业有限公司;四川美大康佳乐药业有限公司3CYHS2301607呋塞米注射液武汉久安药业有限公司;四川美大康佳乐药业有限公司3CYHS2301606氟比洛芬钠滴眼液武汉先路医药科技股份有限公司;成都普什制药有限公司3CYHS2200829氟尿嘧啶注射液湖南赛隆药业（长沙）有限公司;山西普德药业有限公司3CYHS2301428复方聚乙二醇电解质散(III)安徽省先锋制药有限公司4CYHS2301384复方托吡卡胺滴眼液南京恒道医药科技股份有限公司;江苏大红鹰恒顺药业有限公司4CYHS2201645富马酸福莫特罗吸入溶液合肥国药诺和药业有限公司;江苏大红鹰恒顺药业有限公司4CYHS2302287钆布醇注射液常州四药制药有限公司4CYHS2301788钆特酸葡胺注射液山东新时代药业有限公司4CYHS2301815钆特酸葡胺注射液山东新时代药业有限公司4CYHS2301816钆特酸葡胺注射液山东新时代药业有限公司4CYHS2301817钆特酸葡胺注射液Joint Stock Company “FARMAK“5.2JYHS2300001枸橼酸坦度螺酮片山东京卫制药有限公司4CYHS2302793枸橼酸坦度螺酮片山东京卫制药有限公司4CYHS2302794骨化三醇软胶囊湖南银泽华浩生物科技有限公司;南通华山药业有限公司4CYHS2302334己酮可可碱注射液江苏慧聚药业股份有限公司;山西普德药业有限公司3CYHS2300543甲磺酸艾立布林注射液成都西岭源药业有限公司;健进制药有限公司4CYHS2300657甲磺酸仑伐替尼胶囊江苏康缘药业股份有限公司4CYHS2300794甲硫酸新斯的明注射液东阳祥昇医药科技有限公司;浙江北生药业汉生制药有限公司3CYHS2302055甲硫酸新斯的明注射液东阳祥昇医药科技有限公司;浙江北生药业汉生制药有限公司3CYHS2302054间苯三酚口腔崩解片浙江高跖医药科技股份有限公司;浙江赛默制药有限公司3CYHS2301786间苯三酚口腔崩解片湖南先施制药有限公司;浙江赛默制药有限公司3CYHS2301727间苯三酚注射液福建天泉药业股份有限公司4CYHS2302371间苯三酚注射液湖北午时医药研究院有限公司;湖北午时药业股份有限公司4CYHS2301535精氨酸培哚普利片杭州仟源保灵药业有限公司4CYHS2302479精氨酸培哚普利片杭州仟源保灵药业有限公司4CYHS2302478聚乙烯醇滴眼液上海阿尔福斯医药科技有限公司;浙江赛默制药有限公司3CYHS2300992卡贝缩宫素注射液成都诺和晟鸿生物制药有限公司;四川美大康佳乐药业有限公司4CYHS2301732卡铂注射液吉斯美（武汉）制药有限公司4CYHS2301789卡络磺钠注射液成都倍特药业股份有限公司3CYHS2201632卡络磺钠注射液成都倍特药业股份有限公司3CYHS2201631卡络磺钠注射液成都倍特药业股份有限公司3CYHS2201630卡前列素氨丁三醇注射液北京仁众药业有限公司;海南全星制药有限公司4CYHS2302262利奈唑胺干混悬剂广州一品红制药有限公司3CYHS2202052磷酸奥司他韦干混悬剂北京斯利安药业有限公司3CYHS2300958磷酸奥司他韦干混悬剂广东万方药业科技有限公司;哈尔滨三联药业股份有限公司3CYHS2200236磷酸奥司他韦胶囊浙江普洛康裕制药有限公司4CYHS2400689磷酸奥司他韦胶囊遂成药业股份有限公司4CYHS2400586磷酸奥司他韦胶囊遂成药业股份有限公司4CYHS2400588磷酸奥司他韦胶囊遂成药业股份有限公司4CYHS2400585磷酸奥司他韦胶囊天方药业有限公司4CYHS2302571磷酸特地唑胺片石药集团中诺药业（石家庄）有限公司4CYHS2302958硫酸镁钠钾口服用浓溶液丽珠集团丽珠制药厂;天大药业（珠海）有限公司4CYHS2301893硫酸镁钠钾口服用浓溶液南京知和医药科技有限公司;湖南嘉恒制药有限公司4CYHS2301299硫酸羟氯喹片西安海欣制药有限公司4CYHS2302632硫酸特布他林口服溶液成都利尔药业有限公司3CYHS2301327硫酸特布他林口服溶液成都利尔药业有限公司3CYHS2301326硫辛酸注射液江苏开元药业有限公司;江苏悦兴药业有限公司4CYHS2301872铝碳酸镁咀嚼片江右制药（常德）有限公司;江苏永安制药有限公司4CYHS2302099氯化钾颗粒山西普德药业有限公司3CYHS2301126氯化钾注射液黑龙江博宇制药有限公司;湖北科伦药业有限公司3CYHS2302209氯化钾注射液北京柏雅联合药物研究所有限公司;山东华鲁制药有限公司3CYHS2301723氯化钾注射液成都米子生物医药科技有限公司;山东华鲁制药有限公司3CYHS2301596氯化钾注射液成都欣捷高新技术开发股份有限公司;山东华鲁制药有限公司3CYHS2301578氯化钾注射液南京恩泰医药科技有限公司;江苏大红鹰恒顺药业有限公司3CYHS2301547氯雷他定糖浆合肥远志医药科技开发有限公司;安徽永生堂药业有限责任公司4CYHS2302039氯沙坦钾氢氯噻嗪片宁波科尔康美诺华药业有限公司;宁波美诺华天康药业有限公司4CYHS2301692罗库溴铵注射液中玉制药（海口）有限公司;海南中玉药业有限公司4CYHS2301828罗沙司他胶囊重庆煜洋药业有限公司;重庆圣华曦药业股份有限公司4CYHS2303610马来酸阿伐曲泊帕片山东良福制药有限公司4CYHS2302166马来酸阿伐曲泊帕片上海迪赛诺医药集团股份有限公司;江苏诚康药业有限公司4CYHS2301559马来酸阿法替尼片甘肃兰药药业有限公司4CYHS2101073马来酸阿法替尼片甘肃兰药药业有限公司4CYHS2101074马来酸氟伏沙明片湖南省湘中制药有限公司4CYHS2303021马来酸氟伏沙明片山东京卫制药有限公司4CYHS2302834马来酸氟伏沙明片安徽省先锋制药有限公司4CYHS2302391马来酸氟伏沙明片安徽省先锋制药有限公司4CYHS2302390吗啉硝唑氯化钠注射液山东齐都药业有限公司4CYHS2301112吗啉硝唑氯化钠注射液南京卡文迪许生物工程技术有限公司;江苏悦兴药业有限公司4CYHS2300474吗啉硝唑氯化钠注射液成都国为生物医药有限公司;成都正康药业有限公司4CYHS2202045美沙拉秦缓释胶囊北京福元医药股份有限公司3CYHS2302305美索巴莫注射液福安药业集团庆余堂制药有限公司3CYHS2301612米诺地尔搽剂乐福思健康产业股份公司;广东科伦药业有限公司3CYHS2400410米诺地尔搽剂乐福思健康产业股份公司;广东科伦药业有限公司3CYHS2400414米诺地尔搽剂乐福思健康产业股份公司;广东科伦药业有限公司3CYHS2400412莫匹罗星软膏珠海联邦制药股份有限公司中山分公司4CYHS2302064尼可地尔片东阳祥昇医药科技有限公司;浙江北生药业汉生制药有限公司4CYHS2302379尼莫地平注射液成都倍特药业股份有限公司4CYHS2302461帕拉米韦注射液山西阳和医药技术有限公司;山西国润制药有限公司3CYHS2301504帕拉米韦注射液湖北民康药业集团有限公司;湖北美林药业有限公司3CYHS2301271哌柏西利片石药集团欧意药业有限公司4CYHS2400665哌柏西利片南京正大天晴制药有限公司4CYHS2302060哌柏西利片南京正大天晴制药有限公司4CYHS2302061培哚普利氨氯地平片(Ⅲ)江苏万高药业股份有限公司4CYHS2300948苹果酸舒尼替尼胶囊Dr. Reddy's Laboratories Ltd.5.2JYHS2200003泊沙康唑肠溶片Hetero Labs Limited5.2JYHS2200053普伐他汀钠片北京柏雅联合药物研究所有限公司;湖南九典制药股份有限公司4CYHS2302458普拉洛芬滴眼液苏州欧康维视生物科技有限公司4CYHS2302684普拉洛芬滴眼液圣嘉（滨海）生物医药科技有限公司;山东光明药业有限公司4CYHS2302440氢溴酸伏硫西汀片杭州和康药业有限公司4CYHS2301881曲伏前列素滴眼液兆科（广州）眼科药物有限公司4CYHS2302009曲伏噻吗滴眼液兆科（广州）眼科药物有限公司4CYHS2301974屈螺酮炔雌醇片南通联亚药业股份有限公司4CYHS2200411乳果糖口服溶液海南斯达制药有限公司4CYHS2301323乳果糖口服溶液黑龙江中桂制药有限公司4CYHS2300689乳果糖口服溶液黑龙江中桂制药有限公司4CYHS2300690瑞巴派特片苏州旺山旺水生物医药股份有限公司;苏州特瑞药业股份有限公司4CYHS2301934瑞巴派特片北京金城泰尔制药有限公司4CYHS2301916舒更葡糖钠注射液弘和制药有限公司;吉林振澳制药有限公司4CYHS2300937舒更葡糖钠注射液中国大冢制药有限公司4CYHS2300867羧甲司坦口服溶液北京康晟百春生物科技有限公司;北京华润高科天然药物有限公司3CYHS2202114缩宫素注射液安徽百奥药业有限公司;成都利尔药业有限公司3CYHS2301105碳酸司维拉姆片国药集团致君（深圳）坪山制药有限公司4CYHS2301555替米沙坦氨氯地平片山西德元堂药业有限公司4CYHS2302154替米沙坦氨氯地平片康缘华威医药有限公司;江苏康缘药业股份有限公司4CYHS2301967酮咯酸氨丁三醇注射液福建天泉药业股份有限公司3CYHS2301620托拉塞米注射液海南斯达制药有限公司3CYHS2301008托拉塞米注射液海南斯达制药有限公司3CYHS2301009吸入用硫酸沙丁胺醇溶液山东新时代药业有限公司;山东华鲁制药有限公司4CYHS2302678吸入用乙酰半胱氨酸溶液陕西丽彩药业有限公司;太极集团四川太极制药有限公司4CYHS2302648西格列汀二甲双胍片(Ⅱ)浙江英格莱制药有限公司4CYHS2301433西他沙星片浙江麒正药业有限公司4CYHS2302628腺苷注射液北京布霖生物科技有限公司;华夏生生药业（北京）有限公司3CYHS2202062腺苷注射液华夏生生药业（北京）有限公司3CYHS2201223硝苯地平控释片山东新时代药业有限公司4CYHS2302043硝酸异山梨酯注射液安徽誉恒生物科技有限公司;国药集团国瑞药业有限公司4CYHS2302801熊去氧胆酸胶囊宜昌人福药业有限责任公司4CYHS2301832溴莫尼定噻吗洛尔滴眼液山东威智百科药业有限公司;山东海山药业有限公司4CYHS2302136亚叶酸钙注射液石家庄荣雾迪医药科技有限公司;扬州中宝药业股份有限公司4CYHS2302359盐酸艾司洛尔注射液湖南赛隆药业（长沙）有限公司;湖南赛隆药业有限公司3CYHS2301503盐酸奥布卡因滴眼液苏州欧康维视生物科技有限公司4CYHS2301731盐酸贝尼地平片重庆华邦制药有限公司4CYHS2302718盐酸丙卡特罗口服溶液江苏万高药业股份有限公司3CYHS2301818盐酸达泊西汀片齐鲁制药有限公司4CYHS2301837盐酸氮卓斯汀滴眼液合肥华威药业有限公司4CYHS2302951盐酸多巴酚丁胺注射液陕西顿斯制药有限公司3CYHS2302377盐酸多奈哌齐片宝龙药业有限公司4CYHS2201419盐酸多奈哌齐片保定天浩制药有限公司;山东步长制药股份有限公司4CYHS2101423盐酸多奈哌齐片泰荣（福建）药业有限公司;厦门力卓药业有限公司4CYHS2101184盐酸多柔比星脂质体注射液南京绿叶制药有限公司4CYHS2301507盐酸伐地那非片山东海雅医药科技有限公司;南京海纳制药有限公司4CYHS2301955盐酸氟西汀胶囊江西施美药业股份有限公司4CYHS2301682盐酸甲哌卡因注射液济南辰欣医药科技有限公司;辰欣药业股份有限公司3CYHS2301195盐酸甲氧氯普胺注射液安徽长江药业有限公司3CYHS2301976盐酸甲氧氯普胺注射液东阳祥昇医药科技有限公司;浙江北生药业汉生制药有限公司3CYHS2301782盐酸甲氧氯普胺注射液西洲医药科技（浙江）有限公司;浙江北生药业汉生制药有限公司3CYHS2301711盐酸罗匹尼罗缓释片植恩生物技术股份有限公司4CYHS2400314盐酸罗匹尼罗缓释片杭州和泽坤元药业有限公司;广州玻思韬控释药业有限公司4CYHS2301805盐酸莫西沙星氯化钠注射液湖北长联杜勒制药有限公司4CYHS2300870盐酸莫西沙星氯化钠注射液河北凯威恒诚制药有限公司;河北天成药业股份有限公司4CYHS2201999盐酸坦索罗辛缓释胶囊昆明积大制药股份有限公司4CYHS2301617盐酸异丙肾上腺素注射液成都米子生物医药科技有限公司;成都天台山制药股份有限公司3CYHS2302299盐酸左沙丁胺醇雾化吸入溶液海南斯达制药有限公司3CYHS2301485氧氟沙星滴耳液山东光明药业有限公司4CYHS2301752伊布替尼胶囊北京海步医药科技有限公司;北京亚宝生物药业有限公司4CYHS2300103依折麦布片江苏德源药业股份有限公司4CYHS2302773乙酰半胱氨酸泡腾片江苏和晨药业有限公司4CYHS2302616异氟烷山东新时代药业有限公司4CYHS2301172异氟烷山东新时代药业有限公司4CYHS2301171异烟肼注射液嘉实（湖南）医药科技有限公司;湖南五洲通药业股份有限公司3CYHS2301054吲哚布芬片北京诚济制药股份有限公司3CYHS2301349重酒石酸间羟胺注射液河南蓝图制药有限公司;江苏悦兴药业有限公司3CYHS2300889重酒石酸卡巴拉汀口服液百善科技（湖州）有限公司;浙江凯润药业股份有限公司3CYHS2301390重酒石酸去甲肾上腺素注射液武汉久安药业有限公司;朗天药业（湖北）有限公司3CYHS2302220注射用丁二磺酸腺苷蛋氨酸海南倍特药业有限公司4CYHS2300451注射用丁二磺酸腺苷蛋氨酸重庆药友制药有限责任公司4CYHS2300037注射用伏立康唑陕西博森生物制药股份集团有限公司4CYHS2302591注射用氯诺昔康福安药业集团湖北人民制药有限公司4CYHS2301667注射用尼可地尔海南皇隆制药股份有限公司3CYHS2302094注射用尼可地尔海南皇隆制药股份有限公司3CYHS2302095注射用尼可地尔重庆德诚永道医药有限公司;重庆华邦制药有限公司3CYHS2301328注射用头孢米诺钠山东宜和生物医药科技有限公司;山东润泽制药有限公司4CYHS2400781注射用头孢他啶阿维巴坦钠海南海灵化学制药有限公司;海口市制药厂有限公司4CYHS2301941注射用头孢唑肟钠陕西东科制药有限责任公司;上海欣峰制药有限公司4CYHS2301918注射用头孢唑肟钠陕西东科制药有限责任公司;上海欣峰制药有限公司4CYHS2301917注射用盐酸地尔硫卓舒美奇成都生物科技有限公司;峨眉山通惠制药有限公司4CYHS2303042注射用盐酸多西环素海南普利制药股份有限公司3CYHS2201635注射用盐酸多西环素海南普利制药股份有限公司3CYHS2201636注射用盐酸罗沙替丁醋酸酯海南倍特药业有限公司3CYHS2301212注射用吲哚菁绿南京亚东启天药业有限公司;南京海纳制药有限公司3CYHS2300560注射用唑来膦酸浓溶液岳阳新华达制药有限公司4CYHS2300851左卡尼汀口服溶液江苏百奥信康医药科技有限公司;湖南九典制药股份有限公司4CYHS2302472左氧氟沙星滴眼液上海阿尔福斯医药科技有限公司;浙江赛默制药有限公司4CYHS2300873ω-3脂肪酸乙酯90软胶囊扬子江药业集团有限公司4CYHS2300357 注：灰色字体部分受理号结论为不批准。 2、一致性评补充申请获批药品名称企业名称受理号阿奇霉素干混悬剂山东淄博新达制药有限公司CYHB2450159硫酸阿米卡星注射液宁波大红鹰药业股份有限公司;成都市海通药业有限公司CYHB2450025硫酸阿米卡星注射液宁波大红鹰药业股份有限公司;成都市海通药业有限公司CYHB2450026氯化钾注射液石药银湖制药有限公司CYHB2350676葡萄糖酸钙注射液西南药业股份有限公司;石家庄四药有限公司CYHB2350780盐酸林可霉素注射液四川美大康华康药业有限公司CYHB2350880中/长链脂肪乳注射液(C6-24)四川国瑞药业有限责任公司CYHB2350517注射用氨曲南海口市制药厂有限公司CYHB2450015注射用氨曲南海口市制药厂有限公司CYHB2450016 注：灰色字体部分受理号结论为不批准。 3、新增仿制药上市申请药品名称企业名称分类受理号阿戈美拉汀片沈阳华泰药物研究有限公司;沈阳福宁药业有限公司4CYHS2404197阿立哌唑口服溶液浙江浙北药业有限公司3CYHS2404139氨磺必利口服溶液广州艾格生物科技有限公司;湖北唯森制药有限公司3CYHS2404171奥卡西平片湖南省湘中制药有限公司4CYHS2404184奥美沙坦酯口崩片北京星昊盈盛药业有限公司3CYHS2404165苯磺酸左氨氯地平片四川新斯顿制药股份有限公司4CYHS2404138比拉斯汀片广州大光制药有限公司;广州博济生物医药科技园有限公司4CYHS2404193吡拉西坦片海南全星制药有限公司3CYHS2404192玻璃酸钠滴眼液重庆壹零柒陆医药科技有限公司;中山万汉制药有限公司4CYHS2404179玻璃酸钠滴眼液苏州惟佑基因生物科技有限公司;北京汇恩兰德制药有限公司4CYHS2404190布美他尼注射液石家庄四药有限公司3CYHS2404137布南色林片浙江金华康恩贝生物制药有限公司4CYHS2404187布瑞哌唑片天津药物研究院药业有限责任公司4CYHS2404169布瑞哌唑片天津药物研究院药业有限责任公司4CYHS2404170草酸艾司西酞普兰口服溶液海南广升誉制药有限公司;江苏欧歌制药有限公司3CYHS2404136草酸艾司西酞普兰片Maxmind Pharmaceutical S.L.;Macleods Pharmaceuticals Ltd.;Maxmind Biotechnology (Hainan) Co.,Ltd.5.2JYHS2400060草酸艾司西酞普兰片Maxmind Pharmaceutical S.L.;Macleods Pharmaceuticals Ltd.;Maxmind Biotechnology (Hainan) Co.,Ltd.5.2JYHS2400059达格列净片上海现代制药股份有限公司4CYHS2404177达格列净片上海现代制药股份有限公司4CYHS2404178多索茶碱口服溶液华益药业科技（安徽）有限公司3CYHS2404206多种微量元素注射液(Ⅲ)仁合益康汇泽药业河北有限公司4CYHS2404214二甲双胍恩格列净片(Ⅰ)宁波美舒医药科技有限公司;宁波美诺华天康药业有限公司4CYHS2404159二甲双胍恩格列净片(Ⅰ)宁波科尔康美诺华药业有限公司;宁波美诺华天康药业有限公司4CYHS2404147二甲双胍恩格列净片(Ⅲ)宁波科尔康美诺华药业有限公司;宁波美诺华天康药业有限公司4CYHS2404148二甲双胍恩格列净片(Ⅳ)宁波科尔康美诺华药业有限公司;宁波美诺华天康药业有限公司4CYHS2404150二甲双胍恩格列净片(Ⅴ)宁波科尔康美诺华药业有限公司;宁波美诺华天康药业有限公司4CYHS2404152二甲双胍恩格列净片(Ⅵ)宁波科尔康美诺华药业有限公司;宁波美诺华天康药业有限公司4CYHS2404154法莫替丁注射液广东君康药业有限公司;江西赣南海欣药业股份有限公司3CYHS2404140氟伐他汀钠缓释片浙江昂利康制药股份有限公司4CYHS2404228复方氨基酸注射液(20AA)四川科伦药业股份有限公司4CYHS2404196复方电解质醋酸钠葡萄糖注射液南京正科医药股份有限公司;湖南科伦制药有限公司3CYHS2404234复方电解质醋酸钠葡萄糖注射液南京正科医药股份有限公司;湖南科伦制药有限公司3CYHS2404233富马酸伏诺拉生片郑州韩都药业集团有限公司4CYHS2404141富马酸伏诺拉生片郑州韩都药业集团有限公司4CYHS2404143富马酸福莫特罗吸入溶液遂成药业股份有限公司4CYHS2404189富马酸喹硫平缓释片云南先施药业有限公司;山东药石药业有限公司4CYHS2404155富马酸喹硫平缓释片云南先施药业有限公司;山东药石药业有限公司4CYHS2404153腹膜透析液(乳酸盐-G1.5%)广东科泓药业有限公司4CYHS2404215格隆溴铵新斯的明注射液瑞阳制药股份有限公司3CYHS2404162环孢素软胶囊浙江美迪深生物医药有限公司;浙江仟源海力生制药有限公司4CYHS2404167黄体酮注射液南京卡文迪许生物工程技术有限公司;吉林敖东药业集团延吉股份有限公司3CYHS2404227甲氨蝶呤注射液国药一心制药有限公司;贵州阜康仁制药有限公司4CYHS2404151甲氨蝶呤注射液国药一心制药有限公司;贵州阜康仁制药有限公司4CYHS2404149甲钴胺片山东丹红制药有限公司;杨凌步长制药有限公司4CYHS2404182甲磺酸溴隐亭片浙江华海药业股份有限公司4CYHS2404204间苯三酚口腔崩解片南京海纳制药有限公司3CYHS2404166聚乙烯醇滴眼液广州仁恒医药科技股份有限公司;合肥华威药业有限公司4CYHS2404210克立硼罗软膏苏州天马医药集团天吉生物制药有限公司;南京海纳制药有限公司4CYHS2404142兰索拉唑肠溶胶囊石药集团中诺药业（石家庄）有限公司4CYHS2404172利丙双卡因乳膏国大（吉林）制药集团有限公司;南昌立健药业有限公司4CYHS2404200磷酸奥司他韦干混悬剂江西药都仁和制药有限公司3CYHS2404133磷酸奥司他韦胶囊石家庄四药有限公司4CYHS2404188硫酸特布他林注射液西安达莫制药有限公司;陕西金思铭生物技术有限公司3CYHS2404218硫酸特布他林注射液西安达莫制药有限公司;陕西金思铭生物技术有限公司3CYHS2404216罗沙司他胶囊河北紫薇山制药有限责任公司4CYHS2404211罗沙司他胶囊河北紫薇山制药有限责任公司4CYHS2404212吗啉硝唑氯化钠注射液南京黄龙生物科技有限公司;武汉福星生物药业有限公司4CYHS2404157美沙拉秦肠溶片南通联亚药业股份有限公司4CYHS2404195钠钾镁钙注射用浓溶液成都欣捷高新技术开发股份有限公司;山东华鲁制药有限公司3CYHS2404135尼莫地平片湖南科伦制药有限公司4CYHS2404237帕拉米韦氯化钠注射液石家庄四药有限公司4CYHS2404209帕拉米韦氯化钠注射液石家庄四药有限公司4CYHS2404208普拉洛芬滴眼液北京汇恩兰德制药有限公司4CYHS2404146乳果糖口服溶液陕西兴邦药业有限公司;陕西汉唐制药有限公司4CYHS2404221乳果糖口服溶液陕西兴邦药业有限公司;陕西汉唐制药有限公司4CYHS2404223乳果糖口服溶液陕西兴邦药业有限公司;陕西汉唐制药有限公司4CYHS2404219乳果糖口服溶液陕西兴邦药业有限公司;陕西汉唐制药有限公司4CYHS2404220乳果糖口服溶液陕西兴邦药业有限公司;陕西汉唐制药有限公司4CYHS2404222色甘酸钠滴眼液石家庄四药有限公司3CYHS2404207羧基麦芽糖铁注射液仁合益康集团有限公司;河北仁合益康药业有限公司4CYHS2404236羧基麦芽糖铁注射液仁合益康集团有限公司;河北仁合益康药业有限公司4CYHS2404235他达拉非片四川新斯顿制药股份有限公司4CYHS2404199他达拉非片四川新斯顿制药股份有限公司4CYHS2404198碳酸氢钠注射液南京赛瑞谱顿制药有限公司;江苏大红鹰恒顺药业有限公司3CYHS2404225碳酸氢钠注射液南京赛瑞谱顿制药有限公司;江苏大红鹰恒顺药业有限公司3CYHS2404224碳酸司维拉姆干混悬剂山东朗诺制药有限公司3CYHS2404201酮洛芬凝胶广州绿十字制药股份有限公司;乳源东阳光药业有限公司4CYHS2404174酮洛芬凝胶广州绿十字制药股份有限公司;乳源东阳光药业有限公司4CYHS2404173维生素B6注射液山西九康医药科技有限公司;扬州中宝药业股份有限公司3CYHS2404161西吡氯铵含片成都恒瑞制药有限公司3CYHS2404168缬沙坦氨氯地平片(Ⅰ)广州白云山医药集团股份有限公司白云山制药总厂4CYHS2404132盐酸氨溴索口服溶液合肥创新医药技术有限公司;上海海虹实业（集团）巢湖今辰药业有限公司4CYHS2404229盐酸氨溴索口服溶液合肥创新医药技术有限公司;上海海虹实业（集团）巢湖今辰药业有限公司4CYHS2404230盐酸氨溴索口服溶液合肥创新医药技术有限公司;上海海虹实业（集团）巢湖今辰药业有限公司4CYHS2404231盐酸氨溴索口服溶液合肥创新医药技术有限公司;上海海虹实业（集团）巢湖今辰药业有限公司4CYHS2404232盐酸氨溴索片山东济坤生物制药有限公司;山东鲁抗三叶制药有限公司4CYHS2404144盐酸丙卡特罗颗粒浙江恒研医药科技有限公司;浙江赛默制药有限公司3CYHS2404183盐酸丙卡特罗颗粒浙江恒研医药科技有限公司;浙江赛默制药有限公司3CYHS2404185盐酸丙卡特罗颗粒浙江恒研医药科技有限公司;浙江赛默制药有限公司3CYHS2404186盐酸氮卓斯汀滴眼液广东南国药业有限公司4CYHS2404226盐酸普罗帕酮注射液江苏润恒制药有限公司3CYHS2404163盐酸普罗帕酮注射液江苏润恒制药有限公司3CYHS2404164盐酸左沙丁胺醇雾化吸入溶液广州南新制药有限公司3CYHS2404181依帕司他片海南赛立克药业有限公司3CYHS2404160注射用厄他培南钠海南海灵化学制药有限公司4CYHS2404180注射用甲磺酸加贝酯南京泽恒医药技术开发有限公司;津药和平（天津）制药有限公司3CYHS2404194注射用赖氨匹林江西人可医药科技有限公司;山西普德药业有限公司3CYHS2404158注射用赖氨匹林江西人可医药科技有限公司;山西普德药业有限公司3CYHS2404156注射用硫酸艾沙康唑江苏迪赛诺制药有限公司4CYHS2404131注射用硫酸多粘菌素B合肥华威药业有限公司;山东豪瑞恩制药有限公司3CYHS2404191注射用硫酸多粘菌素B山东序列生物科技有限公司;博瑞制药（苏州）有限公司3CYHS2404145注射用氢化可的松琥珀酸钠成都米子生物医药科技有限公司;四川汇宇制药股份有限公司3CYHS2404176注射用氢化可的松琥珀酸钠成都米子生物医药科技有限公司;四川汇宇制药股份有限公司3CYHS2404175注射用头孢唑肟钠安徽杰玺医药有限公司;沈阳三九药业有限公司4CYHS2404203注射用头孢唑肟钠安徽杰玺医药有限公司;沈阳三九药业有限公司4CYHS2404202注射用吲哚菁绿江苏九旭药业有限公司3CYHS2404217左卡尼汀口服溶液山东新华制药股份有限公司;湖南九典制药股份有限公司4CYHS2404213左氧氟沙星滴眼液福建天泉药业股份有限公司;山东海山药业有限公司4CYHS2404205左乙拉西坦口服溶液温岭市创新生物医药科技股份有限公司;万邦德制药集团有限公司4CYHS2404134 4、新增一致性评价补充申报药品名称企业名称受理号艾司唑仑片新乡市常乐制药有限责任公司CYHB2450585布洛芬片山西太原药业有限公司CYHB2450590布洛芬片山西太原药业有限公司CYHB2450589硫酸奈替米星注射液青岛金峰制药有限公司CYHB2450591氯雷他定片浙江京新药业股份有限公司CYHB2450592乳酸钠林格注射液广东大冢制药有限公司CYHB2450595他克莫司胶囊浙江海正药业股份有限公司CYHB2450593他克莫司胶囊浙江海正药业股份有限公司CYHB2450594碳酸氢钠注射液国药集团容生制药有限公司CYHB2450596碳酸氢钠注射液湖北天圣药业有限公司CYHB2450588盐酸甲氧氯普胺注射液河南润弘制药股份有限公司CYHB2450586注射用奥美拉唑钠朗天药业（湖北）有限公司CYHB2450587注射用头孢他啶深圳信立泰药业股份有限公司CYHB2450598注射用头孢他啶深圳信立泰药业股份有限公司CYHB2450597 数据来源：摩熵药筛用摩熵药筛小程序，随时随地查周报

一致性评价

100 项与卡贝缩宫素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D07229	卡贝缩宫素	H01BB03	DB01282

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
宫缩乏力	澳大利亚	Ferring Pharmaceuticals Pty Ltd.	2015-04-17
出血	-	-	-

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
多食症	临床3期	加拿大	ACADIA Pharmaceuticals, Inc.	2023-11-27
多食症	临床3期	英国	ACADIA Pharmaceuticals, Inc.	2023-11-27
多食症	临床3期	美国	ACADIA Pharmaceuticals, Inc.	2023-11-27
普拉德-威利综合症	临床1期	澳大利亚	Levo Therapeutics, Inc.初创企业	2018-11-20
产后出血	临床1期	英国	Ferring Pharmaceuticals A/S	2015-02-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04902729 (Pubmed \| Can J Anaesth)	N/A	-	-	Oxytocin 1 IU iv	遞簾壓積繭憲艱淵鹽衊(構艱築鹹鑰醖鹹壓餘鑰) = 簾積積窪築淵糧窪繭淵網壓鏇壓簾遞壓膚淵選 (遞鬱積遞製繭鑰餘蓋願, 7 ~ 8)	积极	2025-01-06
				Carbetocin 80 µg iv	遞簾壓積繭憲艱淵鹽衊(構艱築鹹鑰醖鹹壓餘鑰) = 築淵範構獵繭蓋網壓遞網壓鏇壓簾遞壓膚淵選 (遞鬱積遞製繭鑰餘蓋願, 8 ~ 9)
NCT03649477 (CARE-PWS, CTgov)	临床3期	普拉德-威利综合症	130	9.6 mg intranasal carbetocin (9.6 mg of LV-101)	廠廠網鏇鑰衊願顧獵積(鑰蓋鏇獵顧築夢鏇選壓) = 鑰鏇願網鹹獵窪簾遞構憲鑰鹹夢憲廠觸遞憲鏇 (鏇窪窪糧餘構簾衊顧選, 積選餘觸積艱鏇鑰衊鑰 ~ 積淵築網獵廠構獵糧築) 更多	-	2021-11-17
				3.2 mg intranasal carbetocin (3.2 mg of LV-101)	廠廠網鏇鑰衊願顧獵積(鑰蓋鏇獵顧築夢鏇選壓) = 遞製製衊繭積遞醖壓網憲鑰鹹夢憲廠觸遞憲鏇 (鏇窪窪糧餘構簾衊顧選, 壓醖構選蓋觸製淵壓選 ~ 積簾壓獵糧鹹廠夢蓋淵) 更多
NCT03716076 (CaRDIO, CTgov)	临床4期	窦性心律失常	50	Carbetocin (Participant Receives 50 mcg of Carbetocin Post-delivery.)	餘獵衊製鑰衊遞顧淵願(鹽衊壓蓋淵鑰憲鹽顧鏇) = 糧顧鹽淵夢衊膚淵膚壓壓衊憲鑰願網鹽顧簾觸 (築構壓夢鹹廠壓鹹觸憲, 範築膚積網衊膚鹹糧鏇 ~ 蓋憲憲鬱齋築簾窪遞鏇) 更多	-	2021-05-14
				Carbetocin (Participant Receives 100 mcg of Carbetocin Post-delivery.)	餘獵衊製鑰衊遞顧淵願(鹽衊壓蓋淵鑰憲鹽顧鏇) = 餘積廠鑰餘鏇夢蓋窪獵壓衊憲鑰願網鹽顧簾觸 (築構壓夢鹹廠壓鹹觸憲, 淵衊構積餘艱壓襯繭夢 ~ 醖顧選餘願繭窪願簾鬱) 更多
NCT03649477 (CARE-PWS, ENDO2021)	临床3期	普拉德-威利综合症 hypothalamic oxytocin levels	119	Carbetocin 3.2 mg	構獵衊顧鏇鑰鹹繭廠糧(構網鬱蓋鬱糧鹽壓構膚) = Numeric trends toward improvement in CY-BOCS scores were observed in each dose arm, but did not reach statistical significance versus placebo 遞蓋艱積憲積觸鏇製積 (夢餘獵築觸鏇鬱簾餘醖 ) 更多	积极	2021-05-03
NCT03649477 (CARE-PWS, BusinessWire) 人工标引	临床3期	普拉德-威利综合症	119	LV-101	鬱鹽遞艱簾鏇壓膚願淵(網遞顧憲糧夢網糧膚廠) = not meet 願鬱選襯膚選願壓製繭 (鹹憲襯鹹夢選蓋願廠選 ) 更多	积极	2020-08-06
				Placebo
NCT03716076 (Pubmed \| Anesth Analg)	临床4期	-	50	Carbetocin 50 µg	襯繭衊網廠獵築築願願(選鏇製鹽範簾淵淵繭構): milliseconds = 4.1 (95% CI, 0.8 ~ 7.5)	-	2020-03-05
				Carbetocin 100 µg
NCT03672045 (Pubmed \| Anaesthesia)	N/A	肥胖	30	Carbetocin	鹹鑰鬱鬱構願遞獵網網(選憲顧壓蓋網積願襯顧) = 鏇範糧獵廠憲鹽齋襯簾繭蓋鬱壓網遞鏇膚餘醖 (齋齋糧廠壓構餘築糧憲, 621 ~ 1178) 更多	-	2020-03-01
NCT02079558 (IRCT, Pubmed \| J Matern Fetal Neonatal Med)	临床2期	产后出血	220	Carbetocin	構淵構範夢襯鬱鹹構憲(選選衊鹹夢鏇構糧繭鬱) = 簾蓋繭鹽鹽廠選觸積襯顧蓋築膚齋蓋選構壓簾 (繭鹽築膚衊淵衊願獵獵 )	-	2018-11-01
				Oxytocin	構淵構範夢襯鬱鹹構憲(選選衊鹹夢鏇構糧繭鬱) = 簾觸獵鬱襯襯蓋觸獵醖顧蓋築膚齋蓋選構壓簾 (繭鹽築膚衊淵衊願獵獵 )
ACTRN12614000870651 (CHAMPION, Pubmed \| N Engl J Med)	临床3期	产后出血	-	Heat-stable carbetocin	衊鹽網遞獵淵願衊鑰壓(鏇網齋壓繭鹽築蓋製鏇) = 簾願製襯鹽窪襯鑰憲憲膚遞夢簾製蓋膚醖廠鏇 (糧窪廠憲鏇襯醖顧選衊 )	-	2018-08-23
				Oxytocin	衊鹽網遞獵淵願衊鑰壓(鏇網齋壓繭鹽築蓋製鏇) = 淵獵膚蓋夢膚鬱艱鏇構膚遞夢簾製蓋膚醖廠鏇 (糧窪廠憲鏇襯醖顧選衊 )
TCTR20160715004 (Pubmed \| Arch Gynecol Obstet)	N/A	怀孕	-	Intravenous carbetocin	艱顧積鬱獵選觸構餘鹹(壓窪積衊鑰鑰鬱鬱範選) = 憲憲範簾構襯獵顧製願膚窪遞遞積簾襯衊鑰窪 (繭網鹽窪襯製夢構範齋 ) 更多	积极	2018-08-01
				Intravenous oxytocin	築膚製製簾鏇齋選遞壓(蓋糧繭膚構齋鏇壓餘遞) = 膚鏇範觸簾鏇範積憲餘襯糧膚憲醖範繭鏇蓋廠 (網顧廠繭鬱願繭窪膚齋 ) 更多