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10.000 international unit(s) Powder and solvent for solution for injection/infusion

Medac Gesellschaft fur Klinische Spezialpraparate mbH EU/1/15/1072/001-002

Main Information

Trade NameSpectrila
Active SubstancesRecombinant l-asparaginase
Strength10.000 international unit(s)
Dosage FormPowder and solvent for solution for injection/infusion
Licence HolderMedac Gesellschaft fur Klinische Spezialpraparate mbH
Licence NumberEU/1/15/1072/001-002

Group Information

ATC CodeL01XX Other antineoplastic agents
L01XX02 asparaginase


Licence Issued14/01/2016
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 Status


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