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

Pfizer Europe MA EEIGEU/1/99/103/002

Main Information

Trade NameReFacto
Active SubstancesRecombinant antihemophilic factor
Strength500 international unit(s)
Dosage FormPowder and solvent for solution for injection
Licence HolderPfizer Europe MA EEIG
Licence NumberEU/1/99/103/002

Group Information

ATC CodeB02BD Blood coagulation factors
B02BD02 coagulation factor VIII


Licence Issued13/04/1999
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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