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Abraxane

5 milligram(s)/millilitre Powder for suspension for infusion

Celgene Europe B.V.EU/1/07/428/001

Main Information

Trade NameAbraxane
Active SubstancesPaclitaxel (formulated as albumin bound nanoparticles)
Strength5 milligram(s)/millilitre
Dosage FormPowder for suspension for infusion
Licence HolderCelgene Europe B.V.
Licence NumberEU/1/07/428/001

Group Information

ATC CodeL01CD Taxanes
L01CD01 paclitaxel

Status

Authorised/WithdrawnAuthorised
Licence Issued11/01/2008
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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