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Medicine Network October 28 - October 26, Colum Pharmaceuticals to imitate the 4 categories of reported propofol / long-chain fat emulsion injection into the administrative approval stage, the product belongs to the nervous system drugs in the anesthetic.
meters intranet data show that there are currently six narcotics have been evaluated by enterprises.
in the field of nervous systems, Colum Pharmaceuticals has two new classification products under review, and no first imitations have been approved.
Source: The National Drug Administration's official website propofol/long-chain fat emulsion is a fast- and short-acting intravenous anesthetic developed by Fessenyuskabi of Germany, widely used in peri-surgical induction, anaesthetic maintenance, and sedation in ICU wards. According to
meters of intranet data, the product in 2019 China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (China's public medical institutions) terminal sales of more than 1.9 billion yuan, an increase of 20.61 percent year-on-year.
12 enterprises submitted propofol in / long-chain fat emulsion consistent evaluation supplementary application or to a new classification of production, Jiangsu Yingke biological products were the first approved production and the same evaluation, the first in China, Colum Pharmaceutical Sprint 2nd review.
Table 1: Anaesthetic over-evaluation Source: Mi-Net MED2.0 China Drug Review Database Mi-Net data show that at present, six narcotics have been evaluated by enterprises, four of which are injections;
Table 2: Nervous system drugs reported in the new classification of Colum Pharmaceuticals Source: MED2.0 China Drug Review Database in the nervous system field, Colum Pharmaceuticals has 4 varieties reported in the new classification, O nitrogen tablets have been successfully approved and treated as the same After evaluation, propofol medium/long-chain fat emulsion entered the administrative approval stage and was approved immediately, and neither of the two varieties reviewed was approved for market as a generic drug, of which the palmine paliperone injection (3 months) was exclusively reported by Colum Pharmaceuticals in a new classification.
source: MiNet database, State Drug Administration