Recombinant Mycobacterium tuberculosis fusion protein (EC) | China Drugs List
Public reference information, not medical advice, a prescription or an offer to supply a medicine. Confirm current approval, availability and suitability with licensed professionals.
- Medicine type
- Biologic
- Therapeutic area
- Prevention & diagnosis
- Indications recorded in the public source
- Diagnosis of Mycobacterium tuberculosis infection. Recommended for infants and children aged 6 months or older and adults under 65 years of age. The skin-test result is not affected by BCG vaccination, and the product can assist the clinical diagnosis of tuberculosis.
- Indication source and scope
- Source date(s): 2024, 2026. Indications transcribed from the public NHSA manufacturer submission; this is not verification of the complete current label.
- Prescribing-information limitations
- A verifiable complete prescribing-information document has not yet been obtained. Available approval records or NHSA submissions support the indications shown; the latest full scope needs confirmation.
- China availability status
- Historical Chinese approval verified; current continuous market availability has not been checked for every product.
- Overseas status
- Market-by-market verification pending.
- Insurance classification
- Included in national insurance (Category B)
- Insurance edition
- 2025 edition; effective 1 January 2026
- Insurance restrictions
- No additional restriction is specified for this formulary entry. General formulary rules and legally approved indications still apply.
- Insurance period
- 2025-01-01 to 2026-12-31
- Insurance verification notes
- Matched by exact or normalized ingredient/formulation name. Reimbursement still depends on the dosage form and listed payment restrictions.
Sources
- https://www.cnpharm.com/upload/resources/file/2021/06/21/92867.docx
- https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf
- https://www.nhsa.gov.cn/attach/Ypsn2024/YPSN202400115/YPSN202400115.pdf
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