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Grafalon 20 mg/ml concentrate for solution for infusion



Neovii Biotech GmbHPA1015/001/001

Main Information

Trade NameGrafalon 20 mg/ml concentrate for solution for infusion
Active SubstancesAnti-human t-lymphocyte immunoglobulin from rabbits
Dosage FormConcentrate for solution for infusion
Licence HolderNeovii Biotech GmbH
Licence NumberPA1015/001/001

Group Information

ATC CodeL04AA Selective immunosuppressants
L04AA04 antithymocyte immunoglobulin (rabbit)

Status

License statusAuthorised
Licence Issued05/06/2001
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceConditions Batches marketed in Ireland shall be subject to control authority batch release by the Paul Ehrlich Institute, Germany. Part of Package leaflet information( It wouldn't fit into the box below) It is strongly recommended that every time that Grafalon is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Marketing StatusMarketed

Documents

Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
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