Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1636309
Name of medicinal product: ABRAXANE
Active substances:
Paclitaxel
Estonian, English, Latin
ATC code: L01CD01
Dosage form: powder for dispersion for infusion
Route of administration: intravenous use
Strengh: 250mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: 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 (see section 4.4). Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Bristol-Myers Squibb Pharma EEIG 
Marketing authorization number: EU/1/07/428 
Marketing authorization issued on: January 11, 2008 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: March 19, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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