Serum Institute of India Reports the CHMP’s Positive Opinion of Siiltibcy as a Diagnostic Aid for Mycobacterium Tuberculosis Infection
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The CHMP has recommended Siiltibcy (0.5μg/mL rdESAT-6 & rCFP-10) to diagnose Mycobacterium tuberculosis infection in individuals (age: ≥28 days), valid in the EU plus Norway, Iceland & Liechtenstein. Separate MAA will be submitted to the UK MHRA
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Siiltibcy’s sensitivity & specificity was assessed in comparison with QuantiFERON TB Gold In-Tube test (QFT, in-vitro test) & Tuberculin purified derivative (PPD RT23, an intradermal test)
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Serum Life Science Europe will be the MAA holder, Bilthoven Biologicals will handle import, release & commercialize Siiltibcy in the EU and Serum Institute of India will oversee manufacturing & regulatory compliance globally under an alliance b/w them
Ref: Serum Institute of India | Image: Serum Institute of India
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
