更新于：2024-05-01

Dimenhydrinate

茶苯海明

更新于：2024-05-01

概要

概要

基本信息

简介苯海拉明 (DPH) 是一种抗组胺剂和镇静剂，主要用于治疗过敏、失眠和普通感冒症状。它可以口服、静脉注射、肌肉注射或涂在皮肤上。最大效果通常在服药后两小时左右出现，效果可持续长达七小时。它是第一代 H1 抗组胺剂和乙醇胺，通过阻断组胺的某些作用发挥作用，从而产生抗组胺剂和镇静作用。苯海拉明也是一种有效的抗胆碱能药。常见的副作用包括嗜睡、协调性差和胃部不适。

药物类型

小分子化药

别名

(O-benzhydryl(dimethylamino)ethanol) 8-chlorotheophyllinate、8-chloro-1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione - 2-(diphenylmethoxy)-N,N-dimethylethanamine (1:1)、Benzhydryl-β-dimethylaminoethylether 8-chlorotheophylline

+ [12]

靶点

H1 receptor

作用机制

H1 receptor拮抗剂(组胺H1受体拮抗剂)

治疗领域

免疫系统疾病神经系统疾病皮肤和肌肉骨骼疾病+ [1]

在研适应症

头晕恶心和呕吐术后恶心呕吐+ [5]

非在研适应症-

原研机构

Church & Dwight Co., Inc.

在研机构

Kowa Co., Ltd.

Yoshindo, Inc.

非在研机构

Watson Laboratories, Inc.

最高研发阶段批准上市

首次获批日期

日本 (1951-09-11),

湿疹昆虫咬伤和螫伤瘙痒+ [1]

最高研发阶段(中国)批准上市

特殊审评-

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结构

分子式C24H28ClN5O3

InChIKeyNFLLKCVHYJRNRH-UHFFFAOYSA-N

CAS号523-87-5

关联

项与茶苯海明相关的临床试验

NCT04606264 / Recruiting临床3期IIT

Randomized, Embedded, Multifactorial Adaptive Platform for Perioperative Medicine at UPMC (UPMC REMAP): Core Protocol - Enhanced Recovery Protocols (ERP)

This REMAP Periop ERP domain study falls under the Periop Core Protocol, which compares the different recommended strategies for enhancing recovery through the use of various standard of care treatments before, during and after surgery in all patients with elective surgical encounters at UPMC who meet eligibility criteria.
The ERP domain seeks to enhance recovery by optimizing strategies of perioperative care through evaluating combinations of perioperative treatment, which consists of preoperative, intraoperative and postoperative care. Optimal combinations of perioperative care will be generated and analyzed to determine the best outcomes for patients as defined by reduction in hospital free days, reduction in postoperative nausea and vomiting, and improved pain control.

开始日期2023-05-15

申办/合作机构

University of Pittsburgh

[+1]

CTR20220781 / CompletedN/A

茶苯海明片在健康受试者中单中心、随机、开放、单次给药、四周期、完全重复交叉的空腹及餐后状态下生物等效性试验

主要目的：以江苏黄河药业股份有限公司生产的茶苯海明片（商品名：宁新宝®）为受试制剂，按生物等效性试验的有关规定，与株式会社陽進堂生产的持证商为Yoshindo Inc.的茶苯海明片（商品名：Dramamine®）为参比制剂，对比在健康人体内的吸收速度及吸收程度，考察两制剂的人体生物等效性。次要目的：观察受试制剂茶苯海明片（商品名：宁新宝®）和参比制剂茶苯海明片（商品名：Dramamine ®）在健康受试者中的安全性。

开始日期2022-06-20

申办/合作机构

江苏黄河药业股份有限公司

NCT05590936 / CompletedN/AIIT

Comparison of the Effectiveness of Dimenydrinate vs Ondasetron on the Prevention of Postoperative Nausea and Vomiting

This study will investigate the impact of dimenydrinate (H1-receptor antagonist) versus ondansetron (HT3-receptor antagonist) in postoperative nausea and vomiting, in surgery-related preoperative stress and in the incidence of postoperative complications that could lengthen the LOS in PACU and/or the overall LOS.

开始日期2018-01-01

申办/合作机构

University of Thessaly

100 项与茶苯海明相关的临床结果

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100 项与茶苯海明相关的转化医学

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100 项与茶苯海明相关的专利（医药）

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482

项与茶苯海明相关的文献（医药）

2023-08-20·Scientific reports

Spectrofluorometric determination of orphenadrine, dimenhydrinate, and cinnarizine using direct and synchronous techniques with greenness assessment.

Article

作者: Rana Ghonim ; Manar M Tolba ; Fawzia Ibrahim ; Mohamed I El-Awady

Orphenadrine (ORP), dimenhydrinate (DMN), and cinnarizine (CNN) were investigated using green-sensitive spectrofluorometric methods. Method, I used for determination of DMN in 0.1 M hydrochloric acid (HCl) and 1.0% sodium dodecyl sulphate (SDS) at 286 nm after λ_ex 222 nm, while for determination of ORP in 1.0% w/v SDS involves measuring the fluorescence at 285 nm after λ_ex 220 nm. For DMN and ORP, the detection and quantitation limits were 2.99 and 4.71 and 9.08 and 14.29 ng/mL, respectively. The ranges of DMN and ORP were 0.10-1.0 and 0.04-0.5 µg/mL, respectively, in micellar aqueous solution. Method II, the derivative intensities of DMN and CNN were measured at a fixed of different wavelength between the excitation and the emission wavelengths (Δλ) = 60 nm at 282 and 322 nm, at the zero crossing of each other, respectively. The detection and quantitation limits for DMN and CNN were 1.77 and 0.88 ng/mL and 5.36 and 2.65 ng/mL, correspondingly, through the entire range of 0.1-1.0 µg/mL for DMN and CNN. The linearity was perfectly determined through the higher values of the correlation coefficient ranging from 0.9997 to 0.9999 for both direct and synchronous methods. The precision of the proposed methods was also confirmed via the lower values of the standard deviation which ranged from 0.39 to 1.11. The technique was expanded to analyze this mixture in combined tablets and laboratory-prepared mixtures. The method validation was done depending on the international conference on harmonization (ICH) recommendations. An analysis of the statistical data revealed a high agreement between the proposed data and the comparison methodology. Three different assessment methods demonstrated the greenness of the technique.

2023-07-01·The British journal of general practice : the journal of the Royal College of General Practitioners

Starting point for improving the approach to vertigo in primary care.

Article

作者: Eva Peguero-Rodriguez ; Jenniffer Perez-Patiño ; Josep Lluís Ballve ; Ivan Villar ; Yolanda Rando ; Jesus Almeda ; Oriol Cunillera ; Olga Lucía Arias ; Xavier González-Compta ; Anna Navarro ; Ricard Carrillo ; Vanessa Monforte

BACKGROUND:

Benign paroxysmal positional vertigo (BPPV) is a prevalent and disabling pathology. Its diagnosis and treatment according to clinical practice guidelines is carried out through canalicular repositioning maneuvers, but these maneuvers are not performed routinely in primary care consultations.

AIM:

To analyse the baseline data from the VERTAP randomised community trial that evaluates whether a blended course is effective in improving the adherence of primary care physicians to clinical practice guidelines.

METHOD:

Baseline data 2021.

SCOPE:

20 primary healthcare centers with an assigned population of 514157.

OUTCOME VARIABLES:

sex, age, diagnoses related to vertigo/dizziness, anti-vertigo medications prescribed, number of referrals to the otolaryngologist and neurologist, complementary examinations, and sick leave.

RESULTS:

Vertigo/dizziness-related diagnoses totaled 21 359 cases, with a prevalence of 4.15%. Women made up 51.49% of cases. Median age was 52.00 (41.00, 65.00) years. Non-specific diagnoses totaled 18 617 (87.16%), including dizziness (n = 13 846, 64.83%), unspecified vestibular function disorder (n = 962, 4.50%), aural vertigo (n = 7, 0.03%), and other (n = 3802, 17.80%). Specific diagnoses totalled 2742 (12.84%), including BPPV (n = 1665, 7.80%), vestibular neuritis (n = 24, 0.11%), Menière's disease (n = 992, 4.64%), and central vertigo (n = 61, 0.29%). Anti-vertigo drugs prescribed included betahistine (n = 13 338, 62.45%), sulpiride (n = 3379, 15.82%), and dimenhydrinate (n = 20, 0.093%). Complementary examinations included computed tomography (n = 5704, 26.70%) and magnetic resonance (n = 604, 2.83%). One temporary disability for work (n = 1468, 6.87%); ≥2 temporary disability for work (n = 275, 1.29%).

CONCLUSION:

The majority of diagnostic records related to vertigo/dizziness were non-specific (9 out of 10). The number of prescriptions for betahistine, and referrals, mainly to an otolaryngologist, are considerable and an avoidable expense. Better knowledge about vertigo/dizziness in care could improve the diagnostic and therapeutic accuracy of this pathology as well as the social and health costs it produces.

2023-05-15·Experimental parasitology

Effects of SQ109 on Trichomonas vaginalis.

Article

作者: Tatiana Guinancio de Souza ; Renato Granado ; Gustavo Benaim ; Wanderley de Souza ; Marlene Benchimol

Trichomonas vaginalis is a protozoan that causes human trichomoniasis, a sexually transmitted infection (STI) that affects approximately 278 million people worldwide. The current treatment for human trichomoniasis is based on 1-(2-hydroxyethyl)-2-methyl-5-nitroimidazole, known as Metronidazole (MTZ). Although effective in eliminating parasitic infection, MTZ is related to serious adverse effects and is not recommended during pregnancy. In addition, some strains are resistant to 5'-nitroimidazoles, prompting the development of alternative drugs for trichomoniasis. Here we show that SQ109 [N-adamantan-2-yl-N'-((E)-3,7-dimethyl-octa- 2,6-dienyl)-ethane-1,2-diamine], a drug under development (antitubercular drug candidate that completed Phase IIb/III) for the treatment of tuberculosis, and previously tested in Trypanosoma cruzi and Leishmania. SQ109 inhibited T.vaginalis growth with an IC50 of 3.15 μM. We used scanning and transmission electron microscopy to visualize the ultrastructural alterations induced by SQ109. The microscopy analysis showed morphological changes on the protozoan surface, where the cells became rounded with increasing surface projections. In addition, the hydrogenosomes increased their size and area occupied in the cell. Furthermore, the volume and a significant association of glycogen particles with the organelle were seen to be altered. A bioinformatics search was done about the compound to find its possible targets and mechanisms of action. Our observations identify SQ109 as a promising compound against T. vaginalis in vitro, suggesting its potential utility as an alternative chemotherapy for trichomoniasis.

项与茶苯海明相关的新闻（医药）

2024-04-03

·PRNewswire

Dramamine® Celebrates its 75th Anniversary by Reviving an Unexpected Partner: The Barf Bag

The nausea-fighting brand is highlighting the cultural impact of barf bags and ushering them into a new era with a documentary, a limited-edition collection of upcycled bags and a custom wearable art piece made from vintage bags TARRYTOWN, N.Y., April 3, 2024 /PRNewswire/ -- 1949 was a big year for barf, welcoming the invention of the barf bag and Dramamine®. Seventy-five years later, Dramamine, a Prestige Consumer Healthcare brand, thrives as the number one brand for motion sickness relief, but as Dramamine has risen in popularity, the use of barf bags has sadly diminished. To commemorate the joint anniversary, Dramamine® is breathing new life – not barf – into the paper product with a mission to save its fellow partner in puke. Continue Reading ‘The Last Barf Bag’ Campaign The Last Barf Bag: A Tribute to a Cultural Icon "The Last Barf Bag" campaign announced today by Dramamine®, alongside agency partners FCB Chicago, 360PR+ and The Shipyard, explores the cultural impact of a humble yet crucial American invention made all but defunct due to Dramamine's effectiveness in preventing unexpected upchucks. Through a new documentary, a collection of upcycled, repurposed bags and a pop-up museum exhibition, Dramamine is paying tribute to a once iconic part of our culture and history, nodding to the manufacturers, collectors, and nausea sufferers as they fill barf bags with new purpose and save their industry from irrelevance. "We're not saying that Dramamine has caused the demise of the barf bag, but we are saying that Dramamine is effective in minimizing their use, and we feel bad about that," said Erica Nesbitt, Senior Brand Manager of Dramamine at Prestige Consumer Health. "The 75th anniversary of both inventions felt like the right time to commemorate barf bags' contributions to culture and even rewrite what the future holds for them after Dramamine's impact has made their intended purpose all but obsolete." 'The Last Barf Bag' Documentary The documentary short film, The Last Barf Bag: A Tribute to a Cultural Icon, explores the cultural impact of a humble but crucially useful American invention. In it, the barf bag collectors and manufacturers whose passion can be credited to saving it from extinction, meet their unlikely ally: the makers of the anti-nausea medication that threatens its existence. Directed by the filmmaking collective Sunny Sixteen (Niles Jeran, Joshua Martin, Taylor Pendleton, and Caleb Babcock), The Last Barf Bag film introduces us to doctors, pilots, historians, collectors, brand managers, suppliers, flight attendants, and even regular people discussing their barf-worthy experiences. 'This is Not A Barf Bag' Limited Edition Collection Dramamine and barf bags have been fighting the good fight against nausea together, but the barf bag can make way for a purpose that goes way beyond catching upchucks. Consumers can get in on the crusade to save culture's cherished paper puke sacks by purchasing upcycled barf bags that can be used as puppets, chef's hats, popcorn bags, coloring canvases, vases and more. Each bag in its repurposed form will be available for purchase for $5, and bundles including a barf bag and Dramamine product will be $10 while supplies last. View the full collection here. Dramamine commissioned artist and creative director known for her appearance on NBC's Making It, Jessie Bearden, to display her craft on a new type of novel canvas…vintage barf bags. Bearden created a custom-made puffer coat using the colorful, patterned barf bags from around the world as material for a unique, only-of-its-kind item and exhibition piece. The puffer can be previewed at TheLastBarfBag.com today through April 17 at 12pm EST, when it will open up for one lucky consumer to secure the ultra-limited edition drop for just $7.50, a nod to the 75th anniversary milestone. "The unique look of vintage barf bags and their various colors and designs actually make a great template for a totally one-of-a-kind textile, and that's what inspired me to create a jacket," said Bearden. "I use a lot of unorthodox materials in my work, but a barf bag is a first! It makes me so happy knowing the piece will give a new life to these barf bags and I hope it serves as a conversation starter for the one lucky person who gets to wear it and spread the news of Dramamine's The Last Barf Bag project." Barf Bag Collection Exhibition Today in New York City for one day only, consumers and passersby can see The Last Barf Bag Exhibition in-person and watch an exclusive screening of the documentary on the day of its world premiere. The extensive collections of four of America's preeminent barf bag collectors will be on full display, including collections consisting of hundreds of bags collected over 5+ decades from around the world and even space. The exhibit will be open to the general public on April 3 from 12pm – 7pm at 437 N. Broadway. Following the exhibition, its collections and contents will be available to be viewed online. Consumers can pay their tributes to the barf bag's cultural impact and secure their piece of barf bag history by visiting TheLastBarfBag.com. Follow @DramamineOfficial for more information. ABOUT DRAMAMINE® Dramamine® is the #1 name in motion related nausea relief. Dramamine®'s range of solutions, in various forms, effectively prevent and treat nausea, dizziness, vomiting & queasiness. The brand falls under the Prestige Consumer Healthcare portfolio, which markets and distributes over-the-counter products in the U.S., Canada and Australia. With 75 years of experience, Dramamine® is the leader in nausea relief with a wide range of solutions created to help Americans unwanted bouts of barf. For more information on Dramamine® products, including Dramamine® Original Formula, Dramamine® Non-Drowsy, and the newest Dramamine® Ginger Chews, and for a list of retailers, visit . ABOUT PRESTIGE CONSUMER HEALTHCARE INC. Prestige Consumer Healthcare is a leading consumer healthcare products company with sales throughout the U.S. and Canada, Australia, and in certain other international markets. The Company's diverse portfolio of brands include Monistat® and Summer's Eve® women's health products, BC® and Goody's® pain relievers, Clear Eyes® and TheraTears® eye care products, DenTek® specialty oral care products, Dramamine® motion sickness treatments, Fleet® enemas and glycerin suppositories, Chloraseptic® and Luden's® sore throat treatments and drops, Compound W® wart treatments, Little Remedies® pediatric over-the-counter products, Boudreaux's Butt Paste® diaper rash ointments, Nix® lice treatment, Debrox® earwax remover, Gaviscon® antacid in Canada, and Hydralyte® rehydration products and the Fess® line of nasal and sinus care products in Australia. Visit the Company's website at . Contact: Megan Miller [email protected] SOURCE Dramamine

2023-05-25

·PRNewswire

Vanda Pharmaceuticals Reports Results from a Phase III study of Tradipitant in Motion Sickness

WASHINGTON, May 25, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the results from its Phase III study of tradipitant in motion sickness, confirming the previously reported results demonstrating that tradipitant is effective in the prevention of vomiting associated with motion sickness. The Phase III study was conducted in real-world conditions on boats in the coastal waters of the United States (U.S.). The Motion Syros study was a multicenter, randomized, double-blind, placebo-controlled study where 365 participants embarked on boat trips under varied sea conditions and received tradipitant 170 mg, tradipitant 85 mg, or placebo. Study participants had a prior history of motion sickness and were distributed across thirty-four boat trips that took place between November 2021 and April 2023. Sea conditions and participant evaluation of the symptoms of motion sickness were recorded for each trip. The primary endpoint of the study was the effect of tradipitant on vomiting induced by motion sickness. Both 170 mg and 85 mg tradipitant doses were shown to be superior to placebo in preventing vomiting with only 18.3% and 19.5% of participants experiencing vomiting on tradipitant 170 mg and 85 mg respectively, as compared to 44.3% of participants on placebo (p < 0.0001 for both). Motion sickness remains an unmet need as various pharmacological and non-pharmacological interventions suffer from low efficacy, substantial side effects, or both. The U.S. Food and Drug Administration (FDA) has not approved a new medication for motion sickness in over forty years, since the approval of scopolamine, a transdermal patch placed behind the ear, in 1979. Vanda plans to continue the motion sickness clinical program and pursue FDA approval upon completion of additional efficacy and safety studies. Table 1: Results of Motion Syros study for the Overall population across all sea conditions Motion sickness Motion sickness is a disorder characterized by a constellation of symptoms, with nausea and vomiting being the primary ones1. Motion sickness has plagued travelers for thousands of years, as evidenced by the ancient Greek physician Hippocrates who wrote "sailing on the sea proves motion disorders the body"1. Historians theorize that motion sickness may have changed the fate of civilization on several occasions, notably the defeat of the Spanish Armada by the English in 1588 and the negative effects on Napoleon's camel corps during the Egyptian campaign in 17982. It is believed that a discrepancy between actual body position and perceived body position triggers the maladaptive response of motion sickness3. Approximately 30% of the general population is reported to suffer from motion sickness under ordinary travel conditions that include sea, air and land travel4. According to IQVIA data, approximately two to three million doses of Dramamine, a common motion sickness remedy, are purchased monthly in the U.S. Dramamine treated patients represent only a fraction of the people treated monthly for motion sickness. Motion sickness is one of the most prevalent episodic disorders in the world, whose prevalence has dramatically increased with world population mobility over the last 100 years. The U.S. Department of Transportation reports 10 billion trips per year in mass transit (buses and trains), with an additional 965 million passenger trips in domestic and international air travel5. References Golding JF. Motion sickness. Handbook of Clinical Neurology. 2016: 371–90. Huppert D, Benson J, Brandt T. A historical view of motion sickness-a plague at sea and on land, also with military impact. Frontiers Neurology. 2017: 8:114. Reason JT. Motion sickness adaptation: a neural mismatch model. Journal of the Royal Society of Medicine. 1988: 71: 819-829. Turner M, Griffin MJ. Motion sickness in public road transport: passenger behavior and susceptibility. Ergonomics. 1999: 42: 444-461. U.S. Department of Transportation, Office of the Secretary of Transportation, Bureau of Transportation Statistics. 2018 Transportation Statistics Annual Report. About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on Twitter @vandapharma. About Tradipitant Tradipitant is a neurokinin-1 receptor antagonist licensed by Vanda from Eli Lilly and Company. Tradipitant is currently in clinical development for gastroparesis and motion sickness. The FDA has imposed a partial clinical hold on tradipitant clinical protocols of longer than 12 weeks duration. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS Various statements in this press release, including, but not limited to statements regarding Vanda's plans to continue the tradipitant motion sickness clinical program and pursue FDA approval, are "forward-looking statements" under the securities laws. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to successfully conduct additional efficacy and safety studies and complete the clinical development of tradipitant in motion sickness. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Elizabeth Van Every Head of Corporate Affairs Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] SOURCE Vanda Pharmaceuticals Inc.

临床3期临床结果

2023-04-02

·米内网

3月6个1类新药，4个改良型新药报产；4个生物类似药获批，11个品种决出首仿

摘要abstract 2023年3月CDE共承办药品注册申请1266件 6个1类新药，4个改良型新药报产仿制申请有34个品种暂无国产获批 9个存量品种首次有企业申报一致性评价 3个创新药、4个生物类似药获批，2个品种获批新适应症 11个首仿品种获批，7个存量品种首家过评CDE总体承办情况据米内网中国申报进度（MED）数据库统计，2023年3月CDE共承办药品注册申请1266件。其中上市申请322件，临床申请221件，存量品种一致性评价89件。2023年1-3月CDE承办药品注册申请情况（按受理号计）创新药品种申报情况2023年3月，111个创新药品种（药品注册分类为1的品种）获CDE承办。其中有6个品种申请上市，其中化学药有3个，中成药有1个，治疗用生物制品2个，广东众生睿创生物的来瑞特韦片已附条件获批。2023年3月创新药上市申请承办情况2023年3月创新药临床申请承办情况改良型新药品种申报情况2023年3月，31个改良型新药品种（药品注册分类为2的品种）获CDE承办，其中4个品种为上市申请。2023年3月改良型新药上市申请承办情况2023年3月改良型新药临床申请承办情况仿制药品种申报情况2023年3月，253个品种的仿制申请获CDE承办，奥贝胆酸片、奥卡西平口服混悬液、巴氯芬口服溶液、苯甲酸钠苯乙酸钠注射液、波生坦片、布地奈德福莫特罗吸入气雾剂、醋酸钙口服溶液、丁酸氯维地平注射用乳剂、多巴丝肼片.....等34个品种目前暂无国产仿制药获批。2023年3月仿制药品种申报情况存量品种一致性评价申报情况2023年3月，54个品种的一致性评价补充申请获CDE承办。其中布美他尼注射液、茶苯海明片、对乙酰氨基酚泡腾颗粒、复方磺胺甲噁唑注射液、铝镁匹林片(Ⅱ)、吲哚布芬片、注射用头孢地嗪钠/氯化钠注射液、注射用头孢唑肟钠、注射用盐酸多柔比星(速溶)等9个品种为首次申报。2023年3月存量品种一致性评价申报情况其他类型申请情况2023年3月，有7个进口原研药、1个治疗用生物制品生物类似药申请上市。2023年3月其他类型品种申请情况获批情况2023年3月有3个创新药获批上市：上海盛迪医药的阿得贝利单抗注射液、上海海和药物研究开发的谷美替尼片以及广东众生睿创生物的来瑞特韦片（附条件批准）。礼来的巴瑞替尼以及拜耳的达罗他胺片获批新适应症。4个生物类似药获批，分别属于正大天晴药业集团南京顺欣制药、江苏泰康生物医药、杭州中美华东制药、海正生物制药。108个仿制药获批，其中阿普米司特片(石药集团欧意药业)、甲磺酸艾立布林注射液(博瑞制药(苏州))、利奈唑胺氯化钠注射液(华夏生生药业(北京))、磷苯妥英钠注射用浓溶液(西安葛蓝新通制药)、硫酸长春新碱注射液(合肥亿帆生物制药)、美沙拉秦肠溶缓释胶囊(海南合瑞制药)、泊沙康唑口服混悬液(湖南科伦制药)、塞瑞替尼胶囊(江苏奥赛康药业)、酮洛芬凝胶贴膏(湖南九典制药)、长链脂肪乳注射液(OO)(深圳市海滨制药)、注射用头孢西丁钠/葡萄糖注射液(湖南科伦制药) 为国内首仿品种。61个存量品种有企业过评，其中阿奇霉素颗粒(沈阳金龙药业)、地西泮注射液(天津金耀药业)、琥珀酰明胶注射液(吉林省长源药业)、美洛昔康胶囊(山东新华制药)、盐酸丙卡特罗片(安徽环球药业)、盐酸多巴酚丁胺注射液(海南普利制药)、盐酸米诺环素胶囊(海口市制药厂) 为首家过评。2023年3月主要注册类型品种获批情况数据来源：米内网中国申报进度数据库（MED）、CDE、NMPA；相关统计字段按药品名称统计，时间截至2023年3月31日；获批品种按NMPA发布时间统计；药物作用靶点以及适应症整理自公开资料。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

上市批准一致性评价生物类似药

100 项与茶苯海明相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00520	茶苯海明	A04A	DB00985

研发状态

适应症	最高研发状态	国家/地区	公司
恶心和呕吐	批准上市	日本更多	Yoshindo, Inc. 更多
湿疹	批准上市	日本更多	Kowa Co., Ltd. 更多
术后恶心呕吐	批准上市	日本更多	Yoshindo, Inc. 更多
荨麻疹	批准上市	日本更多	Kowa Co., Ltd. 更多
头晕	批准上市	日本更多	Yoshindo, Inc. 更多

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01890538 (Pubmed \| Emerg Med J)	临床4期	眩晕	94	Intravenous Dimenhydrinate	簾餘夢簾遞鏇簾構淵製(構醖齋鹽衊製膚齋淵襯) = 鑰夢積窪壓遞簾鹹網願鹽構製膚衊鏇齋衊繭廠 (積積獵鏇憲衊襯憲膚艱 )	不佳	2015-07-01
				Intravenous Piracetam	簾餘夢簾遞鏇簾構淵製(構醖齋鹽衊製膚齋淵襯) = 鹹繭夢鹽簾鑰築憲壓簾鹽構製膚衊鏇齋衊繭廠 (積積獵鏇憲衊襯憲膚艱 )