COMPANY
XELLIA PHARMACEUTICALS APS
XELLIA PHARMACEUTICALS APS: marketing authorisation holder, bulk ingredient labeler for Daptomycin, Vancomycin, Bacitracin, Colistin, as stated by public registers.
Also written as: Xellia Pharmaceuticals ApS.
MARKETING AUTHORISATION HOLDER
Holds the licence to sell the medicine in a country (EMA, MHRA, Health Canada).
| Daptomycin | DAPTOMYCIN 350 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 17815/0065, Authorised Regulator MHRA |
|---|---|
| Daptomycin | DAPTOMYCIN 500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 17815/0066, Authorised Regulator MHRA |
| Daptomycin | DAPTOXEL 350 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 17815/0076, Authorised Regulator MHRA |
| Daptomycin | DAPTOXEL 500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION, PL 17815/0077, Authorised Regulator MHRA |
| Vancomycin | VANCOMYCIN CAPSULES 125MG, PL 17815/0041, Authorised Regulator MHRA |
| Vancomycin | VANCOMYCIN CAPSULES 250MG, PL 17815/0042, Authorised Regulator MHRA |
BULK INGREDIENT LABELER
Lists the bulk active ingredient with FDA (NDC directory).
| Bacitracin | Bacitracin Zinc, BULK INGREDIENT Regulator openFDA |
|---|---|
| Colistin | Colistin Sulfate, BULK INGREDIENT Regulator openFDA |
| Vancomycin | Vancomycin Hydrochloride, BULK INGREDIENT Regulator openFDA |
| Vancomycin | Vancomycin, BULK INGREDIENT Regulator openFDA |
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