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Fanhdi 500 IU powder and solvent for solution for injection

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

Instituto Grifols S.A.PA0849/001/002

Main Information

Trade NameFanhdi 500 IU powder and solvent for solution for injection
Active SubstancesHuman coagulation factor viii
Strength500 international unit(s)
Dosage FormPowder and solvent for solution for injection
Licence HolderInstituto Grifols S.A.
Licence NumberPA0849/001/002

Group Information

ATC CodeB02BD Blood coagulation factors
B02BD02 coagulation factor VIII

Status

Authorised/WithdrawnAuthorised
Licence Issued07/07/2000
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceBatches of finished product marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EC. Batches of human albumin used in manufacture shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EC.
Marketing StatusNot marketed

Documents

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