Siiltibcy (Mycobacterium tuberculosis derived antigens (rdESAT-6 / rCFP-10))
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- Mycobacterium tuberculosis derived antigens (rdESAT-6 / rCFP-10)
- Company
- Serum Life Science Europe GmbH
- Status
- Authorised
- Therapeutic area
- Tuberculosis; Diagnosis
- CHMP opinion
- Thu 17 Oct 2024
- EU approval
- Mon 13 Jan 2025
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006177
- ATC
- V04CF
- Official record
- www.ema.europa.eu
Indication
Diagnosis of infection with Mycobacterium tuberculosis.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.