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ADVATE

2000 international unit(s) Powder and solvent for solution for injection

Takeda Manufacturing Austria AGEU/1/03/271/005

Main Information

Trade NameADVATE
Active SubstancesRecombinant coagulation fviii (octocog alfa)
Strength2000 international unit(s)
Dosage FormPowder and solvent for solution for injection
Licence HolderTakeda Manufacturing Austria AG
Licence NumberEU/1/03/271/005

Group Information

ATC CodeB02BD Blood coagulation factors
B02BD02 coagulation factor VIII

Status

Authorised/WithdrawnAuthorised
Licence Issued
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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