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HELIXATE NEXGEN

1000 International Unit Pdr+Solv for Soln for Inj

Bayer AGEU/1/00/144/003

Main Information

Trade NameHELIXATE NEXGEN
Active SubstancesFACTOR VIII, RECOMBINANT
Strength1000 International Unit
Dosage FormPdr+Solv for Soln for Inj
Licence HolderBayer AG
Licence NumberEU/1/00/144/003

Group Information

ATC CodeB02BD02 Blood coagulation factors

Status

Authorised/WithdrawnAuthorised
Licence Issued04/08/2000
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing Status--Unknown--
Promotion StatusPromotion to Healthcare Professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).

Documents

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