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Notification by the State Food and Drug Administration: Shanghai involved in batches of immunoglobulins and patients, Ai

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Late on the night of February 6, the official website of the State Food and Drug Administration announced the preliminary investigation of emerging related products in Shanghai.from

In Shanghai, the AIDS, hepatitis B, and hepatitis C virus nucleic acid tests were performed on the batch of human immunoglobulins, and the results were all negative; Jiang West faced the patient's HIV nucleic acid test and the result was negative.

The following is the full text of the notification:

from

State Food and Drug Administration announces preliminary investigation of emerging products in Shanghai

On February 5, the State Food and Drug Administration received a notification from the National Health and Health Commission that Shanghai Xinxing Pharmaceutical Co., Ltd. (hereinafter referred to as “Shanghai Xinxing”) produced a batch of intravenous immunoglobulin (batch number: 20180610Z) HIV antibody. Tested as positive. The State Food and Drug Administration immediately requested the Shanghai Food and Drug Administration to conduct on-site inspections of Shanghai Xinxing, organize inspections of the same batch of raw material plasma production products and adjacent batches of products, and dispatched a supervision inspection team to Shanghai and Jiangxi to supervise and guide local medicines. The supervision department carries out investigation and disposal work. The State Food and Drug Administration and the National Health and Health Commission jointly issued a notice requesting the immediate suspension of the use of related products produced by the enterprise and timely taking control measures such as storage.

from

In Shanghai, the AIDS, hepatitis B, and hepatitis C virus nucleic acid tests were performed on the batch of human immunoglobulins, and the results were all negative; Jiang West faced the patient's HIV nucleic acid test and the result was negative.

Relevant work such as on-site verification of enterprises is being further carried out.

Notification by the State Food and Drug Administration: Shanghai involved in batches of immunoglobulins and patients, Ai -Notification-by-the-State-Food-and-Drug-Administration-Shanghai-involved-in-batches-of-immunoglobulins-and-patients-Ai

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National Health Council:

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Require national suspension of use and storage of batches of pharmaceuticals

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On the evening of February 6 from

 The National Health and Wellness Committee responded to the "positive injection of human immunoglobulin HIV positive", sayingfrom

The medical institutions across the country have been required to suspend the use and storage of the company’s problem batch of drugs. , from

 And sent a working group to the local guidance work,from

Experts believe that patients who use the drug have a low risk of contracting AIDS.

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National Health and Wellness Commission's response to questions related to "injection of human immunoglobulin HIV positive":

On February 5, after receiving a report on the HIV-positive status of intravenous immunoglobulin (batch number: 20180610Z), Shanghai Emerging Pharmaceutical Holdings Co., Ltd. immediately notified the State Food and Drug Administration.from

Require all medical institutions across the country to suspend the use and storage of the company's problem batch of drugs from

 Do a good job in observing and monitoring the condition of the relevant patients, and cooperate with the drug regulatory authorities to do a good job investigation and drug disposal. Our committee has sent a working group to the local guidance work for the first time, and convened experts to analyze and judge relevant issues. According to international relevant literature reports, combined with the production process characteristics of the drug inactivated virus and the PH value of the product, etc.from

Experts believe that patients who use the drug have a low risk of contracting AIDS. from

 Our committee has organized a follow-up monitoring program for patients using drugs, in line with the spirit of being highly responsible to the people, guiding the local authorities to follow up the relevant patients, and cooperating with the State Food and Drug Administration to do a good job in the follow-up.

Shanghai Drug Administration Department:

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Conduct a comprehensive investigation!

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On the evening of February 6 from

 Shanghai Pharmaceutical Supervision Department also responded:

Notification by the State Food and Drug Administration: Shanghai involved in batches of immunoglobulins and patients, Ai -1549498765_506_Notification-by-the-State-Food-and-Drug-Administration-Shanghai-involved-in-batches-of-immunoglobulins-and-patients-Ai

On February 5, the State Food and Drug Administration and the State Health and Health Commission issued a notice on the disposal of the relevant batches of the Shanghai New Emerging Pharmaceutical Co., Ltd., and the leaders of the municipal party committee and the municipal government attached great importance to it.from

Require immediate drug discharge and storage work, as soon as possible to find out the facts, from

 Effectively strengthen drug management to ensure the safety of drug use by the masses.

The municipal drug supervision department immediately organized law enforcement personnel and expertsfrom

Entering the production site, conducting investigation and disposal, controlling all relevant production and inspection records of the enterprise, sampling and sampling the products, and requiring the enterprise to stop production and initiate an emergency recall. from

 The Municipal Health and Health Commission has notified the city's medical institutions to suspend the use of related products.

The State Drug Administration has sent a team of experts to Shanghai to conduct on-site inspections of enterprises. At present, the incident is under further investigation.

Shanghai Drug Administration

February 6, 2019

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Late night on February 6 from

 The State Food and Drug Administration announced the preliminary investigation of emerging products in Shanghai.

Reporter: Dai Lili, tension

Part of the content is integrated from the upstream news (Reporter: Shi Tingting)


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