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Drug Basics Drug Name: Benzodiamin Chloride Capsule Dosage Form: Capsule Specification: 5mg Registration Classification: Chemical Drug Registration Standard Number: YBH11142020 Applicant: Lizhu Group Lizhu Pharmaceutical Factory Acceptance Number: CYHB1950442 Approval Conclusion: According to the Drug Administration Law of the People's Republic of China, The State Council The provisions of the Opinions on Reforming the Drug Medical Device Review and Approval System (No. 44 of Guofa (2015)) and the Notice on Matters Related to the Evaluation of the Quality and Efficacy of Generic Drugs (No. 100 of 2017) have been reviewed and the Product has agreed to change the prescribing process and quality standards of this Product through the evaluation of the quality and efficacy of generic drugs.
benzodiaxane chlorpyroid capsule is the National Basic Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drug Catalog (Medical Insurance Issue (2019) No. 46) Class A varieties, adaptive disorders: 1, hypertension.
is suitable for the treatment of hypertension.
can be used alone or in a joint application with other antihypertensive drugs.
2, coronary heart disease.
(1) Chronic Stability Angina: This product is suitable for the treatment of chronic stable angina.
can be applied alone or in a joint application with other anti-angina drugs.
(2) Vascular spastic angina (Prinzmetal's or variant angina): This product is suitable for the treatment of confirmed or suspected vascular spastic angina.
can be used alone or in a joint application with other anti-angina drugs.
(3) Coronary heart disease confirmed by angiosis: angiosis confirmed as coronary heart disease, but the blood score ≥40% of patients without heart failure, this product can reduce the risk of hospitalization due to angina and reduce the risk of coronary artery reconstruction.
the date of disclosure of this announcement, the cumulative direct research and development expenses invested in the consistency evaluation of ammonia chloride capsules are approximately RMB106.931 million.
, a total of 2 enterprises in China hold the production approval of benzodiamin chloride capsules, Lizhu Pharmaceutical Factory is the first to pass the product consistency evaluation of the enterprise.
According to IQVIA sampling statistics estimates, the domestic end-sales amount of ammonia chloride oral preparation products in 2019 was approximately RMB 2,595 million, of which the domestic end-sales amount of phenyl sulfonate chloride capsules in 2019 was approximately RMB16.2059 million.
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