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Product No EMEA/H/C/000778
Brand Name Abraxane
Nonproprietary Name paclitaxel
API paclitaxel
ATC Code L01CD01
Indications Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
Orphan Drug no
Generics no
Marketing Authorization Holder Celgene Europe Ltd ?
Status Authorised
Authorization Date 2008-01-11
Version 18
Condition Approval no
Exceptions no
Biosimilar no
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