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Biotest Pharma GmbHEU/1/09/600/001

Main Information

Trade NameZutectra
Active SubstancesHuman plasma protein >96% immunoglobulins
Hbs antibodies
Dosage FormSolution for injection in pre-filled syringe
Licence HolderBiotest Pharma GmbH
Licence NumberEU/1/09/600/001

Group Information

ATC CodeJ06BB Specific immunoglobulins
J06BB04 hepatitis B immunoglobulin


License statusAuthorised
Licence Issued30/11/2009
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown


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