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GRASTOFIL

48MU/0.5 Millilitre Solution for Injection

Apotex Europe B.V.EU/1/13/877/003-004

Main Information

Trade NameGRASTOFIL
Active SubstancesFILGRASTIM
Strength48MU/0.5 Millilitre
Dosage FormSolution for Injection
Licence HolderApotex Europe B.V.
Licence NumberEU/1/13/877/003-004

Group Information

ATC CodeL03AA02 Colony stimulating factors

Status

Authorised/WithdrawnAuthorised
Licence Issued18/10/2013
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing Status--Unknown--
Promotion StatusPromotion to Healthcare Professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

Documents

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