Pediatric medicine god horse more maud, opaque children under the age of 3 clinical research blank

pediatric medicine god horse moder more murky

“the China business news” reporter survey found that at present, the original medicine & other horse more moder Split the mo & throughout; In the country of origin (Italy) applies only to 3 years of age or older children and adults, the drug was used as a immune stimulants in respiratory tract infection and immunity of lower urinary tract. And the illustrations of the registered in China not only increased the multiple indications, applicable people is expanded to all stages of children.

in January this year, the Italian pediatric infectious disease professional authoritative expert susanna & middot; Esposito said in an interview with xinhua news agency reporters, & other; The drug in Italy and Europe are all above 3 years old children use, we need more research to prove in 6 months to 3 years old children whether can use. Throughout the &;

why instruction not consistent between the two countries in the same kind of drug? Horse moder more applicable people in China expanded to children under the age of 3, the examination and approval of registration, the relevant clinical trials in China?

split of manufacturer & ndash; & ndash; At long industrial co., LTD., said in an interview with our reporter, & other; Like in other countries, the product on the market in China before and passed a series of strict drug development process and review of clinical trials. Throughout the &; To press time, however, the company not to split the mo applicable people in China expanded to children under the age of 3 whether done related clinical trials make positive response.

3 children under the age of the lack of clinical research

public data shows, more horse moder by Poli company listed in Italy in 1993, called Polimod goods. Fidia Italy the permissions also transferred to the company, Roche and MaxPharma company (trade name Pigitil, Axil respectively and Onaka, 1993). In 1996, the drug also in Greece and Mexico (commodity called Adimod) listed.

many maude horse has nearly 20 years in our country. Our correspondent query to the Poli company production of the moder oral liquid (7 ml & times; Ten bottles) the earliest in the domestic registered number of BX970339, registration certificate is valid for 3 years, commodity called split. In 1998, the general office of the state planning commission approved the product retail price is RMB 165/bottle.

split mo, according to Chinese specification & other; Children: acute stage: every time 1 bottle (400 mg/bottle), 2 times a day, two weeks, or as directed by the doctor’s advice. Prevention: every time 1 bottle (400 mg/bottle), once a day, at least 60 days or as directed by the doctor’s advice. The dose is suitable for different age children with different indications. Throughout the &;

however, the Italian released (AIFA) by the drug regulatory agency horse moder Italian instruction indicates that there are more adult recommended dose is 1, 800 mg twice daily or as instructed; Are over the age of 3 years old children recommended dose for 1, 400 mg twice daily or as instructed; No children under the age of 3 recommended dose.

an Italian medical sources told our reporter, this manual cited the use of adults and children 3 years old of above method, but did not write given to children under the age of 3 doses, according to Italian medical practice, this means that it is not recommended is suitable for children under 3 years old.

susanna & middot; Esposito told xinhua, the Italian health systems use drugs containing horse moder composition more & other Very frequent throughout the &; The drug is useful for children aged 3 to prevent disease, especially for the immune system is weak, patients with significant clinical history.

however, susanna & middot; Esposito made it clear that the drug in Italy and Europe are all above 3 years old children use, we need more research to prove in 6 months to 3 years old children whether can use. & other; My overall view of this kind of medicine is for sure, but not abuse or misuse. Throughout the &;

in fact, more horse moder for children under 3 years old of clinical research is basically a blank.

15 January, more than Beijing lang in accordance with the pharmaceutical co., LTD., such as horse maud had joint production enterprise, “Chinese journal of new drugs, 2005, 14 (1) reported in Italy for two multicenter, placebo-controlled, randomized double-blind clinical trial, was named to the 671 cases and 416 cases of preschool children aged 3 ~ 5, and 6 ~ 14 years old of school-age children, the children in the past year happened more than 6 times of winter respiratory infections, fully proved moder treatment more effective. But the clinical trials did not involve children under the age of 3.

horse moder more applicable people in China expanded to children under the age of 3, which contains the risk remains unclear.

expand indications

according to the personage inside course of study introduces, Shanghai pharmaceutical trade co., LTD., the first agent sales company, but selling is not ideal. China-zimbabwe pharmaceutical co., LTD. Since then, tianjin and other domestic manufacturer in accordance with the original four drugs approved the moder and preparation, and allowed to 6 years of protection, until the end of February 4, 2007. While domestic manufacturer from pediatric to obtain, has obtained the good market sales.

our reporter learned that, at present, the company’s total dealers in China is in the Hong Kong stock exchange main board listed Chinese pioneer pharmaceutical holdings co., LTD. (hereinafter referred to as & other; Pioneer pharmaceutical & throughout; , 01345. HK).

in February 2016, pioneer pharmaceutical, Polichem conclude a supplementary agreement with suppliers, the company of the company’s marketing, promotion and distribution rights from mainland China (excluding Hong Kong, Macao and Taiwan) expanded to the whole of China, eight provinces since March 7 to take effect. Split is one of the important products of the company, the benefit of the group by the end of 2014 annual income of about 5%, or accounted for by the six months ended June 30, 2015 the total revenue of about 9%.

in the second half of 2015, due to the split of imported drug registration certificate delays than expected the renewal of museum pass, pioneer pharmaceutical import and sales of the product. As the new license is approved, at the beginning of 2016 pioneer pharmaceutical imports from April 2016 and sales company. 2016, pioneer pharmaceutical sales company’s implementation of operating income of 160 million yuan, a 117.7% increase in 2015.

pioneer pharmaceutical announcement, combing through more than a year of market, the new awarded regional business has a smooth transition to complete marketing rights, not only ensure that the product through the fluid channel to enter the market, and lay a foundation for the product in the national unified layout planning. In mid – 2017, the company split don’t achieve revenue of RMB 95.7 million, a 120.5% growth compared with the same period in 2016.

pioneer pharmaceutical also said that the company will be marketing promotion area expansion of the huge market of deep mining, expand the company’s applicable department, education and patient in the doctor’s products cognitive activity, to continue to improve company’s sales.

the personage inside course of study conservatively estimates that 2017 split mo terminal sales in the domestic market should be more than $300 million.

in fact, the current of horse moder more products sold in the domestic market, besides have import the original split the mo, and Beijing lang in accordance with the pharmaceutical, zhejiang fairy Ju pharmaceutical (7.930, & have spent 0.18, & have spent – 2.22%), jiangsu wuzhong (10.130, & have spent 0.08, & have spent – 0.78%) Jin Shi pharmaceutical medicine, tianjin, Inner Mongolia double pharmaceutical, sun stones (tangshan) pharmaceutical company’s products in China. According to the state food and drug administration institute of medicine economic south m Intranet data show that in 2015 and 2016, the national urban public and public hospitals at the county level, community center of cities and towns and townships of horse moder more total sales in 1.707 billion and 1.707 billion yuan respectively.

the industry believe that horse behind much popular in the moder, indications and manual recommended.

Beijing united family hospital pharmacists, Beijing union medical university medicine master ji mei said, from the point of clinical, horse moder along with more scope has reached almost & other; Tiger balm & throughout; Degree, such as eczema, urticaria were using, this is not scientific from clinical.

split mo, according to Chinese manual & other; Suitable for low immune function of patients with the following: repeated respiratory infection (tracheitis, bronchitis); Ent repeated infection (rhinitis, sinusitis, ear infections, pharyngitis, tonsillitis); Repeated urinary system infection; Repeated infection of department of gynaecology; Can be used for the prevention of acute symptoms of infection, shorten the course of the disease and reduce the severity of the disease, reduce the number of repeated attacks, also can be used as an acute infection in antimicrobial therapy adjuvant & throughout; .

however, our reporter found that horse moder Italian instruction indicates that there are more such drugs in the respiratory tract infection and immunity of lower urinary tract is used as a immune stimulants in the crowd.

a professional engaged in drug registration and approval of the personage inside course of study told our reporter, imported drugs registration in China, more than the country of origin indications, enlarge the applicable people, need according to the improved type new drug application for clinical trials, and clinical research in accordance with requirements.

however, these people said, as long as it is approved by the national food administration of drug safety manual, are compliance. How the drug batch too early, batch is in doubt.

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