On July 21, Haisco issued an announcement stating that its wholly-owned subsidiary, Liaoning Haisco Pharmaceutical Co.
, had recently received the "Drug Registration Certificate" issued by the National Medical Products Administration, and obtained the fatty milk amino acid (17) glucose (11) %) The injection was approved for marketing
Basic situation of drugsBasic situation of drugs
Drug name: Fatty Emulsion Amino Acid (17) Glucose (11%) Injection
Acceptance number: CYHB2007289
Certificate Number: 2021B02081
Drug approval number: National Medicine Standard H20217055
Dosage form: injection
Specification: 900ml [fat emulsion injection (20%) 159ml; compound amino acid injection (17) 188ml; glucose injection (11%) 553ml]
Application items: supplementary application-adding drug specifications, etc.
Registration Classification: Chemicals
Evaluation conclusion: According to the "Drug Administration Law of the People's Republic of China" and related regulations, after review, this product meets the relevant requirements of drug registration, and it is approved to increase this product by 900ml [fat emulsion injection (20%) 159ml; compound amino acid injection ( 17) 188ml; glucose injection (11%) 553ml] specifications, approved drug approval number
It is reported that the company’s fat milk amino acid (17) glucose (11%) injection was approved by the National Medical Products Administration in March 2018.
The approval number is National Medicine Zhunzi H20183051, and the specification is 1440ml (20% fat emulsion injection).
Liquid 255ml; Compound Amino Acid Injection 300ml; 11% Glucose Injection 885ml), the packaging container that directly contacts the medicine is an external barrier bag, a three-layer co-extruded three-compartment bag for infusion
This product is used for adult patients who are unable or dysfunctional or who are contraindicated to take oral/intestinal nutrition
As a parenteral nutrition solution, it can provide nutritional support to maintain the amount of nitrogen, carbohydrates and essential fatty acids required for the body's nitrogen balance
The packaging bag of this product is divided into an inner bag and an outer bag.
An oxygen absorbent is placed between the inner bag and the outer bag.
The inner bag is divided into three independent chambers by two peelable seals, which are respectively filled with glucose injection and compound Amino acid injection and fat emulsion injection
In September 2020, the company submitted a supplementary application for increasing specifications to the Drug Evaluation Center of the National Medical Products Administration and was accepted.
It was approved in July 2021 with a specification of 900ml [fat emulsion injection (20%) 159ml; compound amino acid injection Solution (17) 188ml; glucose injection (11%) 553ml]
The 900ml specification added this time is an effective supplement to the existing 1440ml specification of this product and can meet the clinical needs for small-sized three-chamber bag parenteral nutrition products
Compared with the original specification, the 900ml specification can avoid possible excess energy in clinical use, and is more suitable for supplementary parenteral nutrition (SPN) support, facilitating clinically flexible personalized nutritional support, reducing waste and reducing medical costs
According to data from Minai.
com, the sales of fatty milk amino acid (17) glucose (11%) injection in public and county-level public hospitals in China will exceed RMB 2.
4 billion in 2020